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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 K190023
Device Name BTL-084
Applicant
BTL Industries, Inc.
362 Elm St.
Malborough,  MA  01752
Applicant Contact David Chmel
Correspondent
BTL Industries, Inc.
362 Elm St.
Malborough,  MA  01752
Correspondent Contact David Chmel
Regulation Number878.4400
Classification Product Code
PBX  
Date Received01/04/2019
Decision Date 03/29/2019
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
Predetermined Change
Control Plan Authorized		 No
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