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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K111111
Device Name ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
Applicant
ETHICON ENDO-SURGERY, LLC
4545 CREEK ROAD
CINCINNATI,  OH  45242
Applicant Contact LINDA HILL
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 CREEK ROAD
CINCINNATI,  OH  45242
Correspondent Contact LINDA HILL
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received04/20/2011
Decision Date 06/08/2011
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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