The following data is part of a premarket notification filed by Excelsior Medical Corporation with the FDA for 0.9% Sodium Chloride Injection, Usp - 2.5 Ml In 3 Ml Syringe, 0.9% Sodium Chloride Injection, Usp-3ml In 10 Ml Syringe, 0.9% Sodium Chloride Injection, Usp - 5 Ml In 10 Ml Syringe, 0.9% Sodium Chloride Injection, Usp - 10 Ml In 10 Ml Syringe.
| Device ID | K142620 |
| 510k Number | K142620 |
| Device Name: | 0.9% Sodium Chloride Injection, USP - 2.5 ML In 3 ML Syringe, 0.9% Sodium Chloride Injection, USP-3mL In 10 ML Syringe, 0.9% Sodium Chloride Injection, USP - 5 ML In 10 ML Syringe, 0.9% Sodium Chloride Injection, USP - 10 ML In 10 ML Syringe |
| Classification | Saline, Vascular Access Flush |
| Applicant | Excelsior Medical Corporation 1933 Heck Avenue Neptune, NJ 07553 |
| Contact | John Linfante |
| Correspondent | John Linfante Excelsior Medical Corporation 1933 Heck Avenue Neptune, NJ 07553 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-16 |
| Decision Date | 2014-12-12 |
| Summary: | summary |