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510(k) Summary as required by 807.92(c) DEDC222122 01A. 510K Number K 102281 BI. 510(K) Preparer Company name: Business Association Co., Ltd. Address: Miguel Techno world E Cong 524, #5331 Longstanding
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What is 510k summary dc2221?
510k summary dc2221 is a summary of the safety and effectiveness information required for a medical device to be cleared by the FDA through the 510(k) premarket notification process.
Who is required to file 510k summary dc2221?
The manufacturer or sponsor of a medical device seeking clearance through the 510(k) process is required to file the 510k summary dc2221.
How to fill out 510k summary dc2221?
The 510k summary dc2221 should be filled out with detailed information about the device, its intended use, substantial equivalence to predicate devices, safety and effectiveness data, and any other relevant information requested by the FDA.
What is the purpose of 510k summary dc2221?
The purpose of 510k summary dc2221 is to provide the FDA with a concise summary of the safety and effectiveness data supporting a medical device's clearance through the 510(k) process.
What information must be reported on 510k summary dc2221?
The 510k summary dc2221 must include information about the device, its intended use, comparison to predicate devices, performance data, clinical data, labeling, and any other relevant information requested by the FDA.
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