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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K905314
Device Name ALGODERM ALGINATE WOUND DRESSING
Applicant
Les Laboratorires Brothier, S.A.
7527 Westmoreland Ave.
St Louis,  MO  63105
Applicant Contact EVAN DICK
Correspondent
Les Laboratorires Brothier, S.A.
7527 Westmoreland Ave.
St Louis,  MO  63105
Correspondent Contact EVAN DICK
Classification Product Code
FRO  
Date Received11/28/1990
Decision Date 02/19/1991
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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