Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Dressing, Wound, Drug
510(k) Number K052643
FOIA Releasable 510(k) K052643
Device Name EPICERAM
Applicant
Ceragenix Corporation
1444 Wazee St.
Denver,  CO  80202
Applicant Contact CARL GENBERG
Correspondent
Ceragenix Corporation
1444 Wazee St.
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
Predetermined Change
Control Plan Authorized		 No
-
-