The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Mx350 (series) Control Syringe.
| Device ID | K883094 |
| 510k Number | K883094 |
| Device Name: | MX350 (SERIES) CONTROL SYRINGE |
| Classification | Syringe, Piston |
| Applicant | MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
| Contact | Clint R Lawson |
| Correspondent | Clint R Lawson MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-22 |
| Decision Date | 1988-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688507899 | K883094 | 000 |