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I 1x One Lambda, Inc. Specializing in Medical Microdiagnos tics 2lCQl Cartridge Street, Canola Park. CA 91303-2801 Fax 18181 702-69Q4 Tel (818) 702-0042 onelnmbdn.com Website: http://w. 510(k) SUMMARY

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What is summary for 510k flowpra?

Summary for 510k flowpra is a concise report outlining the key information related to a 510(k) submission.

Who is required to file summary for 510k flowpra?

Medical device manufacturers are required to file a summary for 510k flowpra.

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The summary for 510k flowpra can be filled out by providing essential details of the 510(k) submission in a clear and organized manner.

What is the purpose of summary for 510k flowpra?

The purpose of the summary for 510k flowpra is to give a quick overview of the submitted 510(k) application to regulatory authorities.

What information must be reported on summary for 510k flowpra?

The summary for 510k flowpra must include details such as device description, intended use, indications for use, and pre-market clearance status.

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