The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for Cytosafe Needle.
| Device ID | K844904 |
| 510k Number | K844904 |
| Device Name: | CYTOSAFE NEEDLE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | BAXA CORP., SUB. OF COOK GROUP, INC. P.O. BOX 9327 Denver, CO 80209 |
| Contact | Mary Steggall |
| Correspondent | Mary Steggall BAXA CORP., SUB. OF COOK GROUP, INC. P.O. BOX 9327 Denver, CO 80209 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-17 |
| Decision Date | 1985-02-22 |