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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 K131435
Device Name ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,
Applicant
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact MARICA ARENTZ
Correspondent
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact MARICA ARENTZ
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/20/2013
Decision Date 10/03/2013
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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