Empty EVA Bag

Container, I.v.

Haemotronic S.p.a.

The following data is part of a premarket notification filed by Haemotronic S.p.a. with the FDA for Empty Eva Bag.

Pre-market Notification Details

Device IDK210749
510k NumberK210749
Device Name:Empty EVA Bag
ClassificationContainer, I.v.
Applicant Haemotronic S.p.a. Via Carreri 16 Mirandola,  IT 41037
ContactFranciosi Paola
CorrespondentPaola Franciosi
Haemotronic S.p.a. Via Carreri 16 Mirandola,  IT 41037
Product CodeKPE  
CFR Regulation Number880.5025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-12
Decision Date2021-08-19

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