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MAR 5 10(k) Summary Date prepared Submitter Official contact February 15, 2011, Sandra Grunewald David D'Cruz V.P., Clinical & Regulatory Affairs Resumed Corp. 9001 Spectrum Center Blvd., San Diego

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What is 510k summary accessdata fda?

The 510k summary is a document submitted to the FDA's AccessData database, which provides a summary of the premarket notification (510k) submission for a medical device.

Who is required to file 510k summary accessdata fda?

Manufacturers or sponsors of medical devices who are seeking clearance to market their device in the United States are required to file a 510k summary in the FDA's AccessData database.

How to fill out 510k summary accessdata fda?

To fill out the 510k summary for FDA's AccessData database, manufacturers or sponsors should provide relevant information about their medical device, including device classification, intended use, technological characteristics, and any supporting data or clinical studies.

What is the purpose of 510k summary accessdata fda?

The purpose of the 510k summary in the FDA's AccessData database is to provide a concise overview of the submission for a medical device, allowing the FDA and other stakeholders to review and assess the device's safety and effectiveness.

What information must be reported on 510k summary accessdata fda?

The 510k summary in the FDA's AccessData database should include information such as device description, intended use or indications for use, substantial equivalence to predicate devices, and any relevant data or clinical studies supporting the device's safety and effectiveness.

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