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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 K192224
Device Name BTL-899
Applicant
Btl
362 Elm St.
Marlborough,  MA  01752
Applicant Contact David Chmel
Correspondent
Btl
362 Elm St.
Marlborough,  MA  01752
Correspondent Contact David Chmel
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/16/2019
Decision Date 12/05/2019
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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