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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bandage, liquid
510(k) Number K964016
Device Name TIELLE HYDROPOLYMER FOAM DRESSING
Applicant
JOHNSON & JOHNSON MEDICAL, INC.
2500 ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON,  TX  76004 -0130
Applicant Contact RALPH H LARSEN
Correspondent
JOHNSON & JOHNSON MEDICAL, INC.
2500 ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON,  TX  76004 -0130
Correspondent Contact RALPH H LARSEN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/07/1996
Decision Date 12/31/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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