The following data is part of a premarket notification filed by Excelsior Medical Corp. with the FDA for Sterile Field Saline Pre-filled Syringe(s).
| Device ID | K082837 |
| 510k Number | K082837 |
| Device Name: | STERILE FIELD SALINE PRE-FILLED SYRINGE(S) |
| Classification | Saline, Vascular Access Flush |
| Applicant | EXCELSIOR MEDICAL CORP. 1933 HECK AVE. Neptune, NJ 07753 |
| Contact | John Linfante |
| Correspondent | John Linfante EXCELSIOR MEDICAL CORP. 1933 HECK AVE. Neptune, NJ 07753 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-26 |
| Decision Date | 2008-12-18 |
| Summary: | summary |