The following data is part of a premarket notification filed by Codan Us Corp. with the FDA for Codan Chemospike.
| Device ID | K990711 |
| 510k Number | K990711 |
| Device Name: | CODAN CHEMOSPIKE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | CODAN US CORP. 3511 WEST SUNFLOWER AVE. Santa Ana, CA 92704 -6944 |
| Contact | Fergie Ferguson |
| Correspondent | Fergie Ferguson CODAN US CORP. 3511 WEST SUNFLOWER AVE. Santa Ana, CA 92704 -6944 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-04 |
| Decision Date | 1999-04-13 |