NERIA MULTI SUBCUTANEOUS INFUSION SET
FDA 510(k) clearance K120395 · decided 2012-05-30
Clearance details
- K-number
- K120395
- Device name
- NERIA MULTI SUBCUTANEOUS INFUSION SET
- Applicant
- Unomedical Devices S.A DE C.V.
- Decision
- Substantially Equivalent
- Date received
- 2012-02-08
- Decision date
- 2012-05-30
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Reynosa, MX
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in com recall (Z-1821-2015) | Unomedical As | 2015-06-19 |