510(k) K033916 ยท KPE Container, I.V.
GRI-BAG, GRI-BAG AP
| Applicant | Laboratorios Grifols, S.A., Parets Del Valles, Barcelona, ES |
| Decision | Substantially Equivalent, Dec 30, 2003 |
| Received | Dec 18, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033916
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2006 | Instituto Grifols, S.A. Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri- Terminated |
KPE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.