VIAL2BAG
FDA 510(k) clearance K072759 · decided 2007-12-13
Clearance details
- K-number
- K072759
- Device name
- VIAL2BAG
- Applicant
- Medimop Medical Projects, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-28
- Decision date
- 2007-12-13
- Days to decision
- 76 days
- Clearance type
- Abbreviated
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lionville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only recall (Z-0768-2019) | WEST PHARMA. SERVICES IL, LTD | 2019-01-28 |