The following data is part of a premarket notification filed by Pentaferte S.p.a with the FDA for Pentatrasfu Blood Transfusion Sets.
| Device ID | K041496 |
| 510k Number | K041496 |
| Device Name: | PENTATRASFU BLOOD TRANSFUSION SETS |
| Classification | Set, Blood Transfusion |
| Applicant | PENTAFERTE S.P.A 7240 NW 63 TERRACE Parkland, FL 33067 |
| Contact | Victor Pereira |
| Correspondent | Victor Pereira PENTAFERTE S.P.A 7240 NW 63 TERRACE Parkland, FL 33067 |
| Product Code | BRZ |
| 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 | 2005-06-30 |
| Summary: | summary |