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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 K946245
Device Name TIELLE* HYDROPOLYMER DRESSING
Applicant
JOHNSON & JOHNSON INTERNATIONAL
P.O. BOX 90130
2500 ARBROOK BLVD.
ARLINGTON,  TX  76004
Applicant Contact RALPH H LARSEN
Correspondent
JOHNSON & JOHNSON INTERNATIONAL
P.O. BOX 90130
2500 ARBROOK BLVD.
ARLINGTON,  TX  76004
Correspondent Contact RALPH H LARSEN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received12/22/1994
Decision Date 04/11/1995
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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