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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 K945000
Device Name MULTIDEX HYDROPHILIC WOUND DRESSING
Applicant
Lange Medical Products, Inc.
1676 S. Wolf Rd.
Wheeling,  IL  60090
Applicant Contact LEON FERN
Correspondent
Lange Medical Products, Inc.
1676 S. Wolf Rd.
Wheeling,  IL  60090
Correspondent Contact LEON FERN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/13/1994
Decision Date 11/17/1994
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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