The following data is part of a premarket notification filed by Excelsior Medical Corp. with the FDA for Syrex Heparin Lock Flush Syringe, 1 Unit/ml & 2 Units/ml.
| Device ID | K061497 |
| 510k Number | K061497 |
| Device Name: | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML |
| Classification | Heparin, Vascular Access Flush |
| Applicant | EXCELSIOR MEDICAL CORP. 1933 HECK AVE Neptune, NJ 07753 |
| Contact | John Talarico |
| Correspondent | John Talarico EXCELSIOR MEDICAL CORP. 1933 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 | No |
| Date Received | 2006-05-31 |
| Decision Date | 2007-02-23 |
| Summary: | summary |