Empty EVA Bag

Container, I.v.

Haemotronic, Spa

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

Pre-market Notification Details

Device IDK193528
510k NumberK193528
Device Name:Empty EVA Bag
ClassificationContainer, I.v.
Applicant Haemotronic, Spa 16, Via Carreri Mirandola,  IT 41037
ContactPaola Franciosi
CorrespondentPaola Franciosi
Haemotronic, Spa 16, Via Carreri Mirandola,  IT 41037
Product CodeKPE  
CFR Regulation Number880.5025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-19
Decision Date2020-07-22

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