The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Mx927 Blood Transfer Device.
| Device ID | K913498 |
| 510k Number | K913498 |
| Device Name: | MX927 BLOOD TRANSFER DEVICE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
| Contact | Cathy Chenetski |
| Correspondent | Cathy Chenetski MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-06 |
| Decision Date | 1991-11-27 |