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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 K112033
Device Name ENSEAL G2 TISSUS SEALERS
Applicant
ETHICON ENDO-SUGERY, LLC
4545 CREEK RD.
CINCINNATI,  OH  45242
Applicant Contact DONOVAN MAY
Correspondent
ETHICON ENDO-SUGERY, LLC
4545 CREEK RD.
CINCINNATI,  OH  45242
Correspondent Contact DONOVAN MAY
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HGI  
Date Received07/15/2011
Decision Date 11/08/2011
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
Recalls CDRH Recalls
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