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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. Regulatory Affairs Specialist One Medline Place Mundelein IL 60060 Re K160660 Trade/Device Name Medline Waste Station Regulation Number 21 CFR 870. Type of Use Select one or both as applicable Prescription Use Part 21 CFR 801 Subpart D Over-The-Counter Use 21 CFR 801 Subpart C CONTINUE ON A SEPARATE PAGE IF NEEDED....
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