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 |