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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
M Squared Associates, Inc.
575 Eighth Avenue, 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
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