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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 K020779
Device Name PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
Applicant
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242 -2839
Applicant Contact DOUG KENTZ
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242 -2839
Correspondent Contact DOUG KENTZ
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/11/2002
Decision Date 06/05/2002
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
Recalls CDRH Recalls
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