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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K934608
Device Name BARRIER FABRIC 450 SURGICAL GOWN
Applicant
JOHNSON & JOHNSON MEDICAL, INC.
P.O. BOX 90130
ARLINGTON,  TX  76004 -3130
Applicant Contact LINDA G HILL
Correspondent
JOHNSON & JOHNSON MEDICAL, INC.
P.O. BOX 90130
ARLINGTON,  TX  76004 -3130
Correspondent Contact LINDA G HILL
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/27/1993
Decision Date 04/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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