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Ltd. ODXGH HUWKRLQ President/CEO Denteprise International Inc. / 510k FDA Consulting 100 East Granada Blvd. Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. Suite 219 Ormond Beach Florida 32176 Re K160965 Trade/Device Name SuperLine Regulation Number 21 CFR 872. Type of Use Select one or both as applicable Prescription Use Part 21 CFR 801 Subpart D Over-The-Counter Use 21...
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