FLUID ADMINISTRATION SETS, 15 MICRON
FDA 510(k) clearance K790314 · decided 1979-03-06
Clearance details
- K-number
- K790314
- Device name
- FLUID ADMINISTRATION SETS, 15 MICRON
- Applicant
- Medex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-02-13
- Decision date
- 1979-03-06
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- FPB
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use, Lat recall (Z-1549-2008) | Smiths Medical Asd Inc | 2008-07-30 |