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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled sMisbranding by reference to premarket notifications 21CFR Part 807. Kevin Walls Regulatory Insight Incorporated 33 Golden Eagle Lane Littleton Colorado 80127 BOVBSZ Re K153052 Trade/Device Name Erchonia PL-Touch Regulation Number 21 CFR 890. 5500 Regulatory Class Class II Product Code NHN Dated December 8 2015 Received December 9 2015 Dear Mr. FOR FDA USE ONLY Concurrence of Center for...

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