The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Critikon I.v. Administraion Set.
| Device ID | K850507 |
| 510k Number | K850507 |
| Device Name: | CRITIKON I.V. ADMINISTRAION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
| Contact | Melanie Sabo |
| Correspondent | Melanie Sabo CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-08 |
| Decision Date | 1985-03-07 |