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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 K963656
Device Name FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING
Applicant
ADRI
P.O. BOX 134
PARK FOREST,  IL  60466
Applicant Contact GEORGE H SCHERR
Correspondent
ADRI
P.O. BOX 134
PARK FOREST,  IL  60466
Correspondent Contact GEORGE H SCHERR
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/12/1996
Decision Date 11/12/1996
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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