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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name extracorporeal shock wave device for treatment of diabetic foot ulcers
510(k) Number K191961
Device Name OrthoGold
Tissue Regeneration Technologies
251 Heritage Walk
Woodstock,  GA  30188
Applicant Contact John Warlick
M Squared Associates, Inc
575 Eight Avenue, st 1212
New York,  NY  10018
Correspondent Contact Jennifer A Daudelin
Regulation Number878.4685
Classification Product Code
Date Received07/23/2019
Decision Date 11/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No