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510(k) SUMMARY JA N 1 7 2014 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c). A. Contact Information 1. Manufacturer:
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510k summary is a summary of the safety and effectiveness information submitted to the FDA in a 510k premarket notification.
Manufacturers who plan to market a medical device in the United States through the premarket notification process are required to file a 510k summary.
The 510k summary must be completed with detailed information on the medical device, its intended use, safety and effectiveness data, and any similar devices already on the market.
The purpose of the 510k summary is to provide the FDA with a concise overview of the safety and effectiveness of a medical device in order to support its clearance for marketing in the United States.
The 510k summary must include information on the medical device, its intended use, design, materials, performance data, labeling, and any testing or clinical studies conducted.
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