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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. Regulatory Affairs Specialist One Medline Place Mundelein Illinois 60060 Re K152948 Trade/Device Name Medline Anti-Fog Solution Regulation Number 21 CFR 876. Type of Use Select one or both as applicable Over-The-Counter Use 21 CFR 801 Subpart C Prescription Use Part 21 CFR 801 Subpart D CONTINUE ON A SEPARATE PAGE IF NEEDED....
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