The following data is part of a premarket notification filed by Laboratorios Grifols, S.a. with the FDA for Fleboset Double.
| Device ID | K102590 |
| 510k Number | K102590 |
| Device Name: | FLEBOSET DOUBLE |
| 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 | Sebastian Gascon LABORATORIOS GRIFOLS, S.A. POL. LEVANTE C/CAN GUASCH, 2 Parets Del Valles, Barcelona, ES 08150 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-09 |
| Decision Date | 2011-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28426314792572 | K102590 | 000 |