PENTATRASFU BLOOD TRANSFUSION SETS

Set, Blood Transfusion

PENTAFERTE S.P.A

The following data is part of a premarket notification filed by Pentaferte S.p.a with the FDA for Pentatrasfu Blood Transfusion Sets.

Pre-market Notification Details

Device IDK041496
510k NumberK041496
Device Name:PENTATRASFU BLOOD TRANSFUSION SETS
ClassificationSet, Blood Transfusion
Applicant PENTAFERTE S.P.A 7240 NW 63 TERRACE Parkland,  FL  33067
ContactVictor Pereira
CorrespondentVictor Pereira
PENTAFERTE S.P.A 7240 NW 63 TERRACE Parkland,  FL  33067
Product CodeBRZ  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-04
Decision Date2005-06-30
Summary:summary

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