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Return Medical CorporationPremnarket Notification GlidesheathMKIo AObr510(k) Summary FDA CDR DMC A. Device Name22APReceivedProprietary NameGlidesheathClassification NameCatheter Introducer (as per

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What is mar 510k summary device?

Mar 510k summary device is a summary report submitted to the FDA for a medical device that is substantially equivalent to a previously cleared device under Section 510(k) of the Food, Drug, and Cosmetic Act.

Who is required to file mar 510k summary device?

Manufacturers of medical devices seeking FDA clearance are required to file a mar 510k summary device.

How to fill out mar 510k summary device?

Mar 510k summary device must be filled out with detailed information about the device, its intended use, and how it is substantially equivalent to a previously cleared device.

What is the purpose of mar 510k summary device?

The purpose of mar 510k summary device is to demonstrate to the FDA that a medical device is safe and effective for its intended use.

What information must be reported on mar 510k summary device?

Mar 510k summary device must include information about the device's indications for use, technological characteristics, and any testing or clinical data supporting its safety and efficacy.

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