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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 K081146
Device Name ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
Applicant
ETHICON ENDO-SURGERY, LLC
4545 CREEK ROAD
CINCINNATI,  OH  45242
Applicant Contact Abhilasha Mukherjee
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 CREEK ROAD
CINCINNATI,  OH  45242
Correspondent Contact Abhilasha Mukherjee
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received04/22/2008
Decision Date 06/26/2008
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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