HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
FDA 510(k) clearance K142153 · decided 2015-04-29
Clearance details
- K-number
- K142153
- Device name
- HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
- Applicant
- Teleflexmedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-06
- Decision date
- 2015-04-29
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. RE recall (Z-2514-2023) | MEDLINE INDUSTRIES, LP - Northfield | 2023-09-14 |