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This document contains safety and effectiveness information for the PHT-6500, a dental computed tomography x-ray system, submitted in compliance with FDA regulations.

How to fill out 510k submission - ph

How to fill out 510(k) Submission - PH T-6500 (PH T-6OCFO)

1. Gather all necessary documents required for the 510(k) submission.
2. Identify the appropriate predicate device for comparison.
3. Complete the 510(k) application form with accurate device information, including intended use and technological characteristics.
4. Prepare detailed labeling information including instructions for use and any promotional materials.
5. Compile performance testing data that demonstrates the device is as safe and effective as the predicate device.
6. Include biocompatibility, sterility, or shelf-life data if applicable.
7. Ensure the submission is formatted according to FDA guidelines including sections such as administrative information and declarations.
8. Submit the 510(k) application electronically through the FDA's eSubmission Gateway.

Who needs 510(k) Submission - PH T-6500 (PH T-6OCFO)?

1. Manufacturers of medical devices that are seeking FDA clearance to market their device in the United States and that are comparable to existing approved devices.

People Also Ask about

What is Food, Drug and Cosmetic Act Section 510 K?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

How much does a 510k submission cost?

How Much Does a FDA 510k Approval Cost? The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.

What does it mean to be 510 K exempt?

A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device (see sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic (FD&C) Act).

What does FDA 510 K clearance mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is the Section 510 K of the Federal Food Drug and Cosmetic Act?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

What are the three types of 510k?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What is Section 501 of the Food, Drug and Cosmetic Act?

Section 501(a)(2)(B) of the FD&C Act stipulates that a drug is considered adulterated (poorer in quality by adding another substance) if “the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with

What is 510 K submission?

The FDA's 510(k) submission process is, in a nutshell, a clearance process which every company wanting to bring a medium-risk medical device to the American market must pass through. Almost half of all medical devices used in the United States every day will have passed through the 510(k) route.

For pdfFiller’s FAQs

What is 510(k) Submission - PH T-6500 (PH T-6OCFO)?

The 510(k) Submission - PH T-6500 (PH T-6OCFO) is a premarket submission made to the FDA to demonstrate that a medical device is safe and effective, and is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Submission - PH T-6500 (PH T-6OCFO)?

Manufacturers of medical devices that intend to market their product in the United States must file a 510(k) Submission - PH T-6500 (PH T-6OCFO) if their device is classified by the FDA as requiring premarket notification.

How to fill out 510(k) Submission - PH T-6500 (PH T-6OCFO)?

To fill out the 510(k) Submission - PH T-6500 (PH T-6OCFO), manufacturers must complete the required forms, provide device description, indications for use, comparison to predicate devices, and include relevant performance testing data, along with all necessary documentation.

What is the purpose of 510(k) Submission - PH T-6500 (PH T-6OCFO)?

The purpose of the 510(k) Submission - PH T-6500 (PH T-6OCFO) is to obtain FDA clearance to market a medical device by demonstrating its safety and effectiveness as compared to similar, already marketed devices.

What information must be reported on 510(k) Submission - PH T-6500 (PH T-6OCFO)?

The 510(k) Submission - PH T-6500 (PH T-6OCFO) must include the manufacturer's name, device name, device description, intended use, labeling, substantial equivalence comparison, performance data, and any other relevant information required by the FDA.