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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K161551
Device Name TR-100
Applicant
BTL Industries, Inc.
47 Loring Dr.
Framingham,  MA  01702
Applicant Contact Jan Zarsky
Correspondent
BTL Industries, Inc.
47 Loring Dr.
Framingham,  MA  01702
Correspondent Contact Jan Zarsky
Regulation Number878.4400
Classification Product Code
PBX  
Date Received06/03/2016
Decision Date 09/13/2016
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
Predetermined Change
Control Plan Authorized		 No
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