Does anyone know where I can obtain a copy of the Blue Book Memorandum K95-1, 510(k) Requirements During Firm-Initiated Recalls?
The FDA link ((https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080297.htm) is not working.
Best regards
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Sonia Vale
Mahwah NJ
United States
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