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 |