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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 K103672
Device Name REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
Applicant
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact DENNIS HAHN
Correspondent
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact DENNIS HAHN
Regulation Number878.4750
Classification Product Code
GDW  
Date Received12/16/2010
Decision Date 04/08/2011
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
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