The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Click-on.
Device ID | K040633 |
510k Number | K040633 |
Device Name: | CLICK-ON |
Classification | Set, Administration, Intravascular |
Applicant | UNOMEDICAL A/S AAHOLMVEJ 1-3, OSTED Roskilde, DK Dk-4000 |
Contact | John M Lindskog |
Correspondent | John M Lindskog UNOMEDICAL A/S AAHOLMVEJ 1-3, OSTED Roskilde, DK Dk-4000 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-10 |
Decision Date | 2004-04-01 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLICK-ON 79007393 3066165 Dead/Cancelled |
Unomedical A/S 2004-10-20 |
CLICK-ON 78275585 2939674 Live/Registered |
GRASS GMBH 2003-07-17 |
CLICK-ON 75523653 2443677 Dead/Cancelled |
Norland, Hans 1998-07-22 |