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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 K121600
Model ECR60W
Device Name ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE
Original Applicant
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati,  OH  45242
Original Contact asifa vonhof
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received06/01/2012
Decision Date 07/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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