GREINER VACUETTE QUICKSHIELD COMPLETE
FDA 510(k) clearance K072320 · decided 2007-09-14
Clearance details
- K-number
- K072320
- Device name
- GREINER VACUETTE QUICKSHIELD COMPLETE
- Applicant
- Greiner Bio-One North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-20
- Decision date
- 2007-09-14
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Baldwin, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shie recall (Z-1935-2012) | Greiner Bio-One North America, Inc. | 2012-07-03 |