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    • Extracorporeal Shock Wave Device for Treatment of Chronic Burns

    Extracorporeal Shock Wave Device for Treatment of Chronic Burns

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    Extracorporeal Shock Wave Device for Treatment of Chronic Wounds

    Extracorporeal Shock Wave Device for Treatment of Chronic Wounds

    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...
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    OrthoGold 100TM

    OrthoGold 100TM

    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...
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    FDA Devices and Indications

    FDA Devices and Indications

      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...
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    CLEARANCES

    CLEARANCES

    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...
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    Establishment Registration & Device Listing

    Establishment Registration & Device Listing

    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...
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