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'29Pagel of 6 YORBweatingNew LieintoMedicie510(k) SUMMARY Submitter(APR 1 0 2013Xhale, Inc. (via Assurance Biosense, Inc 701 Heron Avenue Glastonbury, CT 06033 Phone: (860) 61616 10 Fax: (352) 3753133Contact

How to fill out 29 510k summary

How to fill out 29 510k summary

1. To fill out the 29 510k summary, follow these steps:
2. Start by providing the necessary identifying information, such as the device name and the company name.
3. Describe the intended use of the device and provide a detailed explanation of its technological characteristics.
4. Include information on any similar devices already on the market and highlight the differences and advantages of your device.
5. State the objective performance criteria and testing methods used to evaluate the device's safety and effectiveness.
6. Include a summary of any clinical data or published literature supporting the device's safety and performance.
7. Describe any potential risks associated with the device and explain the measures taken to mitigate these risks.
8. Provide a detailed description of the manufacturing process and quality control procedures in place.
9. Include information on the labeling of the device, including any warnings or instructions for use.
10. Attach any relevant supporting documentation, such as test reports, certifications, or previous regulatory clearances.
11. Finally, review the completed summary for accuracy and completeness before submission.

Who needs 29 510k summary?

1. The 29 510k summary is needed by medical device manufacturers who intend to market a new medical device in the United States. This summary is required as part of the 510(k) premarket notification process regulated by the U.S. Food and Drug Administration (FDA). It serves as a concise overview of the device's safety and effectiveness, allowing the FDA to evaluate whether the device is substantially equivalent to a legally marketed device and can be cleared for commercial distribution.

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What is 29 510k summary?

29 510k summary is a summary of a premarket notification submission that provides a description of the device and the basis for the substantial equivalence determination.

Who is required to file 29 510k summary?

Manufacturers who are submitting a premarket notification for a medical device are required to file a 29 510k summary.

How to fill out 29 510k summary?

To fill out a 29 510k summary, the manufacturer must provide a detailed description of the device, the predicate device, and the substantial equivalence reasoning.

What is the purpose of 29 510k summary?

The purpose of 29 510k summary is to demonstrate the substantial equivalence of the new device to a legally marketed predicate device.

What information must be reported on 29 510k summary?

The information reported on a 29 510k summary typically includes device description, intended use, technological characteristics, a comparison with the predicate device, and testing data.