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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. Kevin Walls Regulatory Insight Incorporated 33 Golden Eagle Lane Littleton Colorado 80127 Re K142722 Trade/Device Name 3b Laser 500 3b Laser 200 La-x P 500 La-x P 200 Regulation Number 21 CFR 890. 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...
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