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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K000054
Device Name FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
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
Classification Product Code
KGN  
Date Received01/07/2000
Decision Date 03/13/2000
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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