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SuEORX5.SEP 2b 2007510(K) SUMMARYPrepared date August 21, 2007510(k) ownerSenoRx, Inc. 11 Columbia Also Video, CA 92656 P. 949.362.4800 F. 949.362.3200Contact person Eben GordonDevice nameSenoSonix

How to fill out 510k owner

How to fill out 510k owner

1. To fill out a 510(k) owner form, follow these steps:
2. Start by providing the name and contact information of the owner or holder of the 510(k) submission.
3. Fill in the appropriate sections with details about the owner, such as their address, phone number, and email.
4. If the owner is a firm, include the firm's official name, address, and contact information.
5. Specify whether the owner is a single individual or represents a firm.
6. Provide any additional required information regarding the owner as requested by the form.
7. Review the completed form for accuracy and ensure all necessary information is included.
8. Submit the filled-out 510(k) owner form along with the rest of the required documentation.
9. Wait for further instructions or correspondence regarding the status of the submission.

Who needs 510k owner?

1. Anyone who is submitting a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) needs to include the 510(k) owner information.
2. The owner could be an individual or a firm responsible for the submission and any follow-up communication with the FDA.
3. Medical device manufacturers, distributors, or legal representatives may all need to provide 510(k) owner information depending on their role in the submission process.

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What is 510k owner?

A 510(k) owner refers to the entity or individual responsible for submitting a premarket notification to the FDA for a medical device, demonstrating that the device is safe and effective for its intended use.

Who is required to file 510k owner?

Any manufacturer or importer of a medical device that is not exempt from premarket notification requirements and wishes to market their device in the United States must file a 510(k) application.

How to fill out 510k owner?

To fill out a 510(k), the owner must provide detailed information on the device, including its intended use, description, labeling, and evidence that the device is substantially equivalent to a legally marketed predicate device.

What is the purpose of 510k owner?

The purpose of the 510(k) process is to ensure that medical devices are safe and effective by requiring manufacturers to demonstrate that their device is substantially equivalent to an existing, legally marketed device.

What information must be reported on 510k owner?

The 510(k) submission must include the device name, intended use, description, proposed labeling, and data supporting the claim of substantial equivalence.