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 |