Get the free MAR 1 7 2010 510(K) Summary of Safety and Effectiveness

MAR110 2010 510(k) Summary This summary of 510O(k) safety and effectiveness information visaing submitted in accordance with the requirements of 21 CFR 807.92 The Assigned 510(k) Number is: k093384

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What is mar 1 7 510k?

Mar 1 7 510k refers to a premarket notification submitted to the FDA for certain medical devices.

Who is required to file mar 1 7 510k?

Manufacturers of medical devices are required to file mar 1 7 510k if they intend to market a new medical device in the United States.

How to fill out mar 1 7 510k?

To fill out mar 1 7 510k, manufacturers need to provide information about the medical device, its intended use, design, materials, and any clinical testing that has been conducted.

What is the purpose of mar 1 7 510k?

The purpose of mar 1 7 510k is to demonstrate to the FDA that a new medical device is substantially equivalent to a device that is already legally marketed.

What information must be reported on mar 1 7 510k?

Information that must be reported on mar 1 7 510k includes device description, intended use, technological characteristics, performance data, and any nonclinical or clinical testing results.