GRI-BAG, GRI-BAG AP
FDA 510(k) clearance K033916 · decided 2003-12-30
Clearance details
- K-number
- K033916
- Device name
- GRI-BAG, GRI-BAG AP
- Applicant
- Laboratorios Grifols, S.A.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-18
- Decision date
- 2003-12-30
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- KPE
- Device class
- 2
- Regulation number
- 880.5025
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Parets Del Valles, Barcelona, ES
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 mic recall (Z-0906-06) | Instituto Grifols, S.A. | 2006-05-25 |