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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 K182682
Device Name OrthoGold 100
Applicant
Tissue Regeneration Technologies
251 Heritage Walk
Woodstock,  GA  30188
Applicant Contact John Warlick
Correspondent
Msquared Associates, Inc.
575 Eighth Ave.
Suite 1212
New York,  NY  10018
Correspondent Contact Jennifer A. Daudelin
Regulation Number890.5660
Classification Product Code
ISA  
Date Received09/26/2018
Decision Date 12/21/2018
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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