Get the free Revised 510(k) Summary 20171121 (003).pdf

Vedanta International SA Ms. Elizabeth Rose Manager, Regulatory Affairs MAPI USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504November 29, 2017Re: K170690 Trade/Device Name: Vision

How to fill out revised 510k summary 20171121

How to fill out revised 510k summary 20171121:

1. Start by carefully reviewing the revised 510k summary form, ensuring you understand all the information and requirements.
2. Gather all the necessary documentation and supporting materials related to your medical device or product.
3. Begin filling out the form by providing the required general information, such as the company name, product name, and contact details.
4. Proceed to provide a comprehensive description of the medical device or product, including its intended use, indications, and any relevant technical specifications.
5. Describe the performance characteristics of the device, including its design, materials used, and any unique features that distinguish it from similar products.
6. Provide an overview of any clinical studies or testing performed on the device, including the objectives, methodologies, and results.
7. Include any relevant labeling information, such as warnings, precautions, and instructions for use.
8. If applicable, mention any sterilization, packaging, or manufacturing processes involved in the production of the device.
9. Ensure all required sections and fields are completed accurately and thoroughly, double-checking for any errors or omissions.
10. Finally, sign and date the revised 510k summary form, certifying the accuracy and completeness of the information provided.

Who needs revised 510k summary 20171121?

1. Manufacturers of medical devices or products that require a 510k submission to the U.S. Food and Drug Administration (FDA).
2. Regulatory affairs professionals or consultants responsible for preparing and submitting 510k applications.
3. Quality assurance and compliance personnel involved in ensuring the accuracy and completeness of regulatory documentation for medical devices.
4. FDA reviewers and evaluators who assess the submitted 510k summaries to determine the device's safety and effectiveness.

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What is revised 510k summary 20171121?

The revised 510k summary 20171121 is a document submitted to the FDA to update information on a previously cleared 510(k) submission.

Who is required to file revised 510k summary 20171121?

Manufacturers of medical devices who have previously submitted a 510(k) clearance.

How to fill out revised 510k summary 20171121?

The revised 510k summary 20171121 should be filled out by providing updated information on the medical device, including any changes or improvements.

What is the purpose of revised 510k summary 20171121?

The purpose of the revised 510k summary 20171121 is to inform the FDA of any changes or updates to a previously cleared medical device and to demonstrate continued compliance with regulations.

What information must be reported on revised 510k summary 20171121?

The revised 510k summary 20171121 must include information on any changes to the device design, labeling, indications for use, or other relevant details.