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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 And Burn, Occlusive
510(k) Number K946292
Device Name BIODERM MEDICAL COMPOSITE WOUND 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
Classification Product Code
MGP  
Date Received12/27/1994
Decision Date 02/06/1995
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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