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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 -2839
Applicant Contact MELISSA WALKER
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
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
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