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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 K213344
Device Name BTL-899A
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  
Date Received10/07/2021
Decision Date 01/05/2022
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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