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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 K143559
Device Name XP1000 RF
Applicant
BTL Industries, Inc.
47 Loring Dr.
Framingham,  MA  01702
Applicant Contact Jan Zarsky
Correspondent
Mmp Medical Associates, LLC
16 Appleton St.
Waltham,  MA  02453
Correspondent Contact Michail Pankratov
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/16/2014
Decision Date 06/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02271672
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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