The following data is part of a premarket notification filed by Laboratorios Grifols, S.a. with the FDA for Gri-bag, Gri-bag Ap.
| Device ID | K033916 |
| 510k Number | K033916 |
| Device Name: | GRI-BAG, GRI-BAG AP |
| 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 | Susan Gill 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 | 2003-12-18 |
| Decision Date | 2003-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28426314604035 | K033916 | 000 |
| 28426314391416 | K033916 | 000 |
| 28426314391478 | K033916 | 000 |
| 28426314391485 | K033916 | 000 |
| 28426314546830 | K033916 | 000 |
| 08426314575683 | K033916 | 000 |
| 08426314575690 | K033916 | 000 |
| 28426314580810 | K033916 | 000 |
| 08426314580823 | K033916 | 000 |
| 28426314583507 | K033916 | 000 |
| 08426314604024 | K033916 | 000 |
| 28426314391393 | K033916 | 000 |