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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 K101520
Device Name ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
Applicant
Ethicon Endo-Surgery, Inc.
4545 Creek Rd. Ml#132
Cincinatti,  OH  45242
Applicant Contact RUTH WOOD
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd. Ml#132
Cincinatti,  OH  45242
Correspondent Contact RUTH WOOD
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HGI  
Date Received06/02/2010
Decision Date 12/10/2010
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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