The following data is part of a premarket notification filed by Laboratorios Grifols, S.a. with the FDA for Set Gri-fill 3.0-1 Way, 2 Ways, Multiple.
| Device ID | K050339 |
| 510k Number | K050339 |
| Device Name: | SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | LABORATORIOS GRIFOLS, S.A. C/CAN GUASCH, 2 Parets Del Valles, Barcelona, ES 08150 |
| Contact | Sebastian Gascon |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-02-11 |
| Decision Date | 2005-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28426314601164 | K050339 | 000 |
| 28426314601157 | K050339 | 000 |
| 28426314601140 | K050339 | 000 |
| 08426314575768 | K050339 | 000 |