The following data is part of a premarket notification filed by Spectra Medical Devices, Inc. with the FDA for Sodium Chloride Injection, 0.9%, Usp 5 Ml, 10 Ml Ampule.
| Device ID | K103740 |
| 510k Number | K103740 |
| Device Name: | SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE |
| Classification | Saline, Vascular Access Flush |
| Applicant | SPECTRA MEDICAL DEVICES, INC. 3000 K ST., NW Washington, DC 20007 |
| Contact | David L Rosen, B.s. Pharm., J.d. |
| Correspondent | David L Rosen, B.s. Pharm., J.d. SPECTRA MEDICAL DEVICES, INC. 3000 K ST., NW Washington, DC 20007 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-22 |
| Decision Date | 2011-07-29 |
| Summary: | summary |