The following data is part of a premarket notification filed by Laboratorios Grifols, S.a. with the FDA for Gri-fill Peristaltic Set.
| Device ID | K162216 |
| 510k Number | K162216 |
| Device Name: | GRI-FILL PERISTALTIC SET |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | LABORATORIOS GRIFOLS, S.A. C/CAN GUASCH, 2 Parets Del Valles,, ES 08150 |
| Contact | Marta Daniela Serra De Fortuny |
| Correspondent | Marta Daniela Serra De Fortuny LABORATORIOS GRIFOLS, S.A. C/CAN GUASCH, 2 Parets Del Valles,, 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 | 2016-08-08 |
| Decision Date | 2017-10-19 |
| Summary: | summary |