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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 K110049
Device Name REUSABLE LINEAR STAPLER HANDLE
Applicant
ETHICON ENDO-SURGERY, LLC
4545 CREEK ROAD
CINCINNATI,  OH  45242
Applicant Contact DENNIS HAHN
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 CREEK ROAD
CINCINNATI,  OH  45242
Correspondent Contact DENNIS HAHN
Regulation Number878.4750
Classification Product Code
GDW  
Date Received01/07/2011
Decision Date 02/10/2011
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
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