The following data is part of a premarket notification filed by Ceragenix Corporation with the FDA for Epiceram.
| Device ID | K052643 |
| 510k Number | K052643 |
| Device Name: | EPICERAM |
| Classification | Dressing, Wound, Drug |
| Applicant | CERAGENIX CORPORATION 1444 WAZEE STREET Denver, CO 80202 |
| Contact | Carl Genberg |
| Correspondent | Carl Genberg CERAGENIX CORPORATION 1444 WAZEE STREET Denver, CO 80202 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-26 |
| Decision Date | 2006-04-11 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EPICERAM 86287961 4663550 Live/Registered |
PRIMUS PHARMACEUTICALS, INC. 2014-05-21 |
![]() EPICERAM 78620014 3240549 Dead/Cancelled |
PURACAP PHARMACEUTICAL LLC 2005-04-29 |
![]() EPICERAM 73556148 1388713 Dead/Cancelled |
DELTA PLASTICS COMPANY 1985-08-30 |
![]() EPICERAM 73181580 1117522 Dead/Cancelled |
DELTA PLASTICS COMPANY 1978-08-07 |