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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 K970079
Device Name PROXIMATE DISPOSABLE SKIN STAPLER
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Applicant Contact LORRI CHAVEZ
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Correspondent Contact LORRI CHAVEZ
Regulation Number878.4740
Classification Product Code
GAG  
Subsequent Product Code
GDT  
Date Received01/09/1997
Decision Date 03/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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