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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. 5200 3. Predicate Devices K032843 Nexiva Closed IV Catheter System K021120 Radial Artery Catheterization Set with Integral Needle Protection 4. Prescription Use X Part 21 CFR 801 Subpart D AND/OR Over-The-Counter Use 21 CFR 801 Subpart C PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED Concurrence of...
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