The following data is part of a premarket notification filed by Codan Us Corp. with the FDA for Extension Set Light-safe, Model Bc565.
| Device ID | K021480 |
| 510k Number | K021480 |
| Device Name: | EXTENSION SET LIGHT-SAFE, MODEL BC565 |
| Classification | Set, Administration, Intravascular |
| Applicant | CODAN US CORP. 3511 WEST SUNFLOWER AVE. Santa Ana, CA 92704 -6944 |
| Contact | Marilyn R Pourazar |
| Correspondent | Marilyn R Pourazar CODAN US CORP. 3511 WEST SUNFLOWER AVE. Santa Ana, CA 92704 -6944 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-08 |
| Decision Date | 2002-06-27 |