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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stapler, Surgical
510(k) Number K932476
Device Name PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER
Applicant
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact MELISSA WALKER
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact MELISSA WALKER
Regulation Number878.4740
Classification Product Code
GAG  
Subsequent Product Codes
GCJ   GDW  
Date Received05/24/1993
Decision Date 12/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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