The following data is part of a premarket notification filed by Univec, Inc. with the FDA for Univec Auto-disable Hypodermic Syringe.
Device ID | K993996 |
510k Number | K993996 |
Device Name: | UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE |
Classification | Syringe, Antistick |
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 | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-24 |
Decision Date | 2000-07-17 |