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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. It is intended for a single user. 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. Ltd. DYH Kim President Mtech Group 8310 Buffalo Speedway Houston TX 77025 Re K160274 Trade/Device Name Hi Bebeplus model...
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