The following data is part of a premarket notification filed by Laboratorios Grifols, S.a. with the FDA for Gri-flex, Models 1000ml, 500ml, 250ml, 100ml.
| Device ID | K031419 |
| 510k Number | K031419 |
| Device Name: | GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML |
| Classification | Container, I.v. |
| Applicant | LABORATORIOS GRIFOLS, S.A. POL. LEVANTE C/CAN GUASCH, 2 Parets Del Valles, Barcelona, ES 08150 |
| Contact | Sebastian Gascon |
| Correspondent | Pamela Gwynn UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | KPE |
| Subsequent Product Code | FPB |
| Subsequent Product Code | NEP |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-05-05 |
| Decision Date | 2003-11-24 |
| Summary: | summary |