STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE— 510(k) K082689
Substantially EquivalentSpectra Medical Devices, Inc.
FDA 510(k) clearance K082689 for STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE, Substantially Equivalent on 2009-03-20. Applicant: Spectra Medical Devices, Inc..
Clearance details
- Applicant
- Spectra Medical Devices, Inc.
- Product code
- Code NGT
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Adverse events under product code NGT
product code NGT- Death
- 12
- Malfunction
- 2,008
- Other
- 4
- Total
- 2,024
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.