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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 K070887
Device Name ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
Applicant
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Blue Ash,  OH  45242
Applicant Contact DENNIS HAHN
Correspondent
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Blue Ash,  OH  45242
Correspondent Contact DENNIS HAHN
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/30/2007
Decision Date 05/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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