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A separate report is required for each standard referenced in the 510 k. TYPE OF 510 K SUBMISSION Traditional STANDARD TITLE Special Abbreviated Yes Please answer the following questions No Is this standard recognized by FDA 2. FDA Recognition number 3. Was a third party laboratory responsible for testing conformity of the device to this standard identified in the 510 k. Is a summary report 4 describing the extent of conformance of the standard used included in the 510 k. If no complete a summa ...

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