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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled sMisbranding by reference to premarket notifications 21CFR Part 807. 4210 Regulatory Class Class II Product Code DWF Dated August 31 2015 Received September 2 2015 Dear Ms. Prescription Use X Part 21 CFR 801 Subpart D AND/OR Over-The-Counter Use 21 CFR 807 Subpart C PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH Office of Device Evaluation ODE 3...
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