The following data is part of a premarket notification filed by Covalon Technologies Ltd. with the FDA for Covagen.
| Device ID | K123756 |
| 510k Number | K123756 |
| Device Name: | COVAGEN |
| Classification | Dressing, Wound, Collagen |
| Applicant | COVALON TECHNOLOGIES LTD. 405 BRITANNIA ROAD EAST SUITE 106 Mississauga, Ontario, CA L4z 3e6 |
| Contact | Christopher Fredric |
| Correspondent | Christopher Fredric COVALON TECHNOLOGIES LTD. 405 BRITANNIA ROAD EAST SUITE 106 Mississauga, Ontario, CA L4z 3e6 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-07 |
| Decision Date | 2013-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00825439013489 | K123756 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COVAGEN 85720150 not registered Dead/Abandoned |
Covalon Technologies Ltd. 2012-09-04 |
![]() COVAGEN 85712452 4487046 Live/Registered |
Covagen AG 2012-08-24 |