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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K222556
Device Name BTL-785X
Applicant
BTL Industries Inc.
362 Elm Street
Marlborough,  MA  01752
Applicant Contact David Chmel
Correspondent
BTL Industries Inc.
362 Elm Street
Marlborough,  MA  01752
Correspondent Contact David Chmel
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
PBX  
Date Received08/23/2022
Decision Date 05/31/2023
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
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