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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 K940404
Device Name ALGINATE FIBER TOPICAL WOUND DRESSING
Applicant
ADRI
P.O. BOX 134
PARK FOREST,  IL  60466
Applicant Contact GEORGE H SCHERR, PH.D.
Correspondent
ADRI
P.O. BOX 134
PARK FOREST,  IL  60466
Correspondent Contact GEORGE H SCHERR, PH.D.
Regulation Number880.5090
Classification Product Code
KMF  
Date Received01/27/1994
Decision Date 05/04/1994
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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