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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. Corina Duffy Regulatory Associate Medical Components Inc. MedComp 1499 Delp Drive Harleysville PA 19438 Re 510 k Number K142315 Trade/Device Name MINOP Disposable Introducer Regulation Number 21 CFR 882. Type of Use Select one or both as applicable Prescription Use Part 21 CFR 801 Subpart D Over-The-Counter Use 21 CFR 801...
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