The following data is part of a premarket notification filed by Laboratorios Grifols, S.a. with the FDA for Fleboset Multiple.
| Device ID | K040456 |
| 510k Number | K040456 |
| Device Name: | FLEBOSET 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 | 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 | 2004-02-23 |
| Decision Date | 2004-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28426314583521 | K040456 | 000 |