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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 K080972
Device Name ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP
Applicant
Ethicon Endo-Sugery, LLC
4545 Creek Rd.
Blue Ash,  OH  45242
Applicant Contact RUTH A WOOD
Correspondent
Ethicon Endo-Sugery, LLC
4545 Creek Rd.
Blue Ash,  OH  45242
Correspondent Contact RUTH A WOOD
Regulation Number878.4750
Classification Product Code
GDW  
Date Received04/04/2008
Decision Date 07/03/2008
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
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