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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 K052643
FOIA Releasable 510(k) K052643
Device Name EPICERAM
Applicant
CERAGENIX CORPORATION
1444 WAZEE STREET
DENVER,  CO  80202
Applicant Contact CARL GENBERG
Correspondent
CERAGENIX CORPORATION
1444 WAZEE STREET
DENVER,  CO  80202
Correspondent Contact CARL GENBERG
Classification Product Code
FRO  
Date Received09/26/2005
Decision Date 04/11/2006
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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