The following data is part of a premarket notification filed by Excelsior Medical Corp. with the FDA for Syrex Pre-filled Syringe.
| Device ID | K023740 |
| 510k Number | K023740 |
| Device Name: | SYREX PRE-FILLED SYRINGE |
| Classification | Heparin, Vascular Access Flush |
| Applicant | EXCELSIOR MEDICAL CORP. 1923 HECK AVE. Neptune, NJ 07753 |
| Contact | David Lumia |
| Correspondent | David Lumia EXCELSIOR MEDICAL CORP. 1923 HECK AVE. Neptune, NJ 07753 |
| Product Code | NZW |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2002-11-07 |
| Decision Date | 2003-05-13 |