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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 K980451
Device Name BIODERM CALCIUM ALGINATE DRESSING
Applicant
Bioderm, Inc.
P.O. Box 4882
Wheaton,  IL  60189
Applicant Contact GEORGE WORTHLEY
Correspondent
Bioderm, Inc.
P.O. Box 4882
Wheaton,  IL  60189
Correspondent Contact GEORGE WORTHLEY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received02/05/1998
Decision Date 04/09/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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