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November 26, 2019Tissue Regeneration Technologies LLC℅ Jennifer DaudelinRegulatory Consultant IIIM Squared Associates, Inc575 Eight Avenue, St. Suite 1212New York, New York 10018 Re: K191961Trade/Device Name: OrthoGoldRegulation Number: 21 CFR 878.4685Regulation Name: Extracorporeal Shock Wave Device for Treatment of Chronic WoundsRegulatory...

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)   December 21, 2018 Tissue Regeneration Technologies, LLC o Jennifer Daudelin, MSJ Regulatory Consultant III M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New...

  Orthogold 100/ Dermagold 100* Orthogold 100/ Dermagold 100/ Urogold 100* FDA Device Class Class I, K182682 Therapeutic massager Class II, K191961 Extracorporeal Shock Wave Device for Treatment of Chronic Wounds Class II, K200926 Extracorporeal Shock Wave Device for Treatment...

Lithotriptor, Extracorporeal Shock-Wave, Urological – LithoGold Proprietary Name: LithoGold Classification Name: LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE, UROLOGICAL Product Code: LNS Device Class: 2 Regulation Number: 876.5990 Medical Specialty: Gastroenterology Registered Establishment Name: SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC Registered Establishment Number: 3006066512 Premarket...

Establishment: SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC 195 Chastain Meadows Court Suite 109 Kennesaw,  GA  30144 Registration Number: 3006066512 FEI Number*: 3006066512 Status: Active Initial Distributor/Importer: Yes *Note Firm May Have Additional Establishment Types. Please Review Listings For Further Information. Date Of Registration Status: 2022Owner/Operator: TISSUE...