The following data is part of a premarket notification filed by Pentaferte S.p.a with the FDA for Pentadeflue Iv Solution Administration Sets.
| Device ID | K041495 |
| 510k Number | K041495 |
| Device Name: | PENTADEFLUE IV SOLUTION ADMINISTRATION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | PENTAFERTE S.P.A LOC. NOCELLA STATALE 262 Campli (teramo), IT 64012 |
| Contact | Vittorio Servidori |
| Correspondent | Vittorio Servidori PENTAFERTE S.P.A LOC. NOCELLA STATALE 262 Campli (teramo), IT 64012 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-04 |
| Decision Date | 2005-04-15 |
| Summary: | summary |