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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K242532
Device Name BTL-785BNF-E
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 Number882.5890
Classification Product Code
NFO  
Date Received08/26/2024
Decision Date 12/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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