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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wound dressing kit
510(k) Number K951476
Device Name E-PACK PROCEDURE KITS
Applicant
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact JOHN D PAULSON
Correspondent
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact JOHN D PAULSON
Regulation Number880.5075
Classification Product Code
MCY  
Date Received03/30/1995
Decision Date 05/23/1995
Decision Substantially Equivalent - Kit (SESK)
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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