The following data is part of a premarket notification filed by Univec, Inc. with the FDA for Univec Two Piece Syringe.
| Device ID | K000747 |
| 510k Number | K000747 |
| Device Name: | UNIVEC TWO PIECE SYRINGE |
| Classification | Syringe, Piston |
| Applicant | UNIVEC, INC. 22 DUBON CT. Farmingdale, NY 11735 |
| Contact | S. Levinson |
| Correspondent | S. Levinson UNIVEC, INC. 22 DUBON CT. Farmingdale, NY 11735 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-07 |
| Decision Date | 2000-06-08 |