STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
FDA 510(k) clearance K082689 · decided 2009-03-20
Clearance details
- K-number
- K082689
- Device name
- STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
- Applicant
- Spectra Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-15
- Decision date
- 2009-03-20
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- NGT
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9% recall (Z-2873-2026) | Spectra Medical Devices, Llc | 2026-08-11 |