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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K200382
Device Name BTL-703-2
362 Elm Street
Marlborough,  MA  01752
Applicant Contact David Chmel
362 Elm Street
Marlborough,  MA  01752
Correspondent Contact David Chmel
Regulation Number890.5850
Classification Product Code
Date Received02/18/2020
Decision Date 01/06/2021
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