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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. 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. Yayuan Chang Executive Vice General Manager 2F. No.92 96 Luke 5th Rd. Kaohsiung City 82151 TAIWAN Re K152576 Trade/Device Name Anker II Dental Implant...
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