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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 K982939
Device Name BTF THIN FILM WOUND DRESSING
Applicant
Bioderm, Inc.
9705 International Ct. N.
St. Petersburg,  FL  33716
Applicant Contact MARIE B TEIXEIRA
Correspondent
Bioderm, Inc.
9705 International Ct. N.
St. Petersburg,  FL  33716
Correspondent Contact MARIE B TEIXEIRA
Classification Product Code
MGP  
Date Received08/21/1998
Decision Date 10/13/1998
Decision Substantially Equivalent (SESE)
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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