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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 K112056
Device Name ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
Original Applicant
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati,  OH  45242
Original Contact asifa vonhof
Regulation Number878.4750
Classification Product Code
GDW  
Date Received07/19/2011
Decision Date 12/19/2011
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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