The following data is part of a premarket notification filed by Univec, Inc. with the FDA for Univec Non-reusable Syringe.
Device ID | K933469 |
510k Number | K933469 |
Device Name: | UNIVEC NON-REUSABLE SYRINGE |
Classification | Syringe, Antistick |
Applicant | UNIVEC, INC. 1205 FRANKLIN AVE. Garden City, NY 11530 |
Contact | Joel Schnoenfeld |
Correspondent | Joel Schnoenfeld UNIVEC, INC. 1205 FRANKLIN AVE. Garden City, NY 11530 |
Product Code | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-16 |
Decision Date | 1996-04-18 |
Summary: | summary |