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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 K892927
Device Name PROXIMATE LINEAR CUTTER THICK TISSUE INST.
Applicant
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact JAMES O'DONNELL
Correspondent
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact JAMES O'DONNELL
Regulation Number878.4740
Classification Product Code
GAG  
Date Received04/21/1989
Decision Date 05/26/1989
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
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