PULMOSAL
FDA 510(k) clearance K130091 · decided 2013-03-13
Clearance details
- K-number
- K130091
- Device name
- PULMOSAL
- Applicant
- Pharmacaribe
- Decision
- Substantially Equivalent
- Date received
- 2013-01-15
- Decision date
- 2013-03-13
- Days to decision
- 57 days
- Clearance type
- Special
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -f recall (Z-0795-2016) | Pharmacaribe llc | 2016-02-10 |