The following data is part of a premarket notification filed by Spectra Medical Devices, Inc. with the FDA for Sterile Sodium Chloride 0.9% Flush, 5ml, 10ml, Ampule.
| Device ID | K082689 |
| 510k Number | K082689 |
| Device Name: | STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE |
| Classification | Saline, Vascular Access Flush |
| Applicant | SPECTRA MEDICAL DEVICES, INC. 3000 K ST., NW Washington, DC 20007 |
| Contact | David L Rosen |
| Correspondent | David L Rosen 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 | 2008-09-15 |
| Decision Date | 2009-03-20 |
| Summary: | summary |