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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 K954728
Device Name PROD NO. 01-1694 - 4X4 FOAM DRESSING
Applicant
CONTINENTAL MEDICAL LABORATORIES, INC.
P.O. BOX 306
817 MOHR AVENUE
WATERFORD,  WI  53185
Applicant Contact JOSEPH DUNN
Correspondent
CONTINENTAL MEDICAL LABORATORIES, INC.
P.O. BOX 306
817 MOHR AVENUE
WATERFORD,  WI  53185
Correspondent Contact JOSEPH DUNN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/13/1995
Decision Date 09/23/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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