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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K210451
Device Name OrthoGold 100
Applicant
Tissue Regeneration Technologies, LLC
251 Heritage Walk
Woodstock,  GA  30188
Applicant Contact John Warlick
Correspondent
M Squared Associates, INC
127 West 30th St Floor 9
New York,  NY  10001
Correspondent Contact Cherita James
Regulation Number890.5660
Classification Product Code
ISA  
Date Received02/16/2021
Decision Date 05/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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