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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 K955399
Device Name MULTIDEX PLUS HYDROPHILIC WOUND DRESSING
Applicant
LANGE MEDICAL PRODUCTS, INC.
1676 SOUTH WOLF RD.
WHEELING,  IL  60090
Applicant Contact LEON FERN
Correspondent
LANGE MEDICAL PRODUCTS, INC.
1676 SOUTH WOLF RD.
WHEELING,  IL  60090
Correspondent Contact LEON FERN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received11/24/1995
Decision Date 02/07/1996
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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