The following data is part of a premarket notification filed by Univec, Inc. with the FDA for Piston Syringe.
| Device ID | K961877 |
| 510k Number | K961877 |
| Device Name: | PISTON SYRINGE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | UNIVEC, INC. 999 FRANKLIN AVE. Garden City, NY 11530 |
| Contact | Richard Savadsky |
| Correspondent | Richard Savadsky UNIVEC, INC. 999 FRANKLIN AVE. Garden City, NY 11530 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-10 |
| Decision Date | 1996-08-07 |
| Summary: | summary |