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//, .07e;1S Page 1 of 3 510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92 (a) (1) Submitted by: HealthSTATS International PTE. Ltd. 6 New Industrial Road #0401/02 Hoe Heat
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What is 510k summary of safety?
The 510k summary of safety is a document that provides a concise summary of the safety and effectiveness of a medical device.
Who is required to file 510k summary of safety?
Manufacturers of medical devices who are seeking clearance from the FDA are required to file a 510k summary of safety.
How to fill out 510k summary of safety?
The 510k summary of safety should be filled out with detailed information on the safety and efficacy of the medical device being submitted for clearance.
What is the purpose of 510k summary of safety?
The purpose of the 510k summary of safety is to provide the FDA with a comprehensive overview of the safety and effectiveness of the medical device in question.
What information must be reported on 510k summary of safety?
The 510k summary of safety must include information on the device's design, materials, intended use, and any known risks or hazards.
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