The following data is part of a premarket notification filed by Laboratorios Grifols, S.a. with the FDA for Set Gri-fill 2.0-1 Way; 2.0-2 Ways; Luer Connection Tube.
| Device ID | K033682 |
| 510k Number | K033682 |
| Device Name: | SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE |
| Classification | Set, I.v. Fluid Transfer |
| 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 | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-11-24 |
| Decision Date | 2003-12-17 |
| Summary: | summary |