Empty EVA Bag
K-Number: K193528 · 2020-07-22
ApplicantHaemotronic S.P.A.
Decision Date2020-07-22
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Empty EVA Bag is a medical device manufactured by Haemotronic S.P.A.. It received FDA 510(k) clearance on 2020-07-22 under approval number K193528. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Empty EVA Bag?
Empty EVA Bag is a medical device that received FDA 510(k) clearance on 2020-07-22. It is manufactured by Haemotronic S.P.A.. The 510(k) number is K193528.
When was Empty EVA Bag approved by the FDA?
Empty EVA Bag received FDA 510(k) clearance on 2020-07-22, under approval number K193528.
What company makes Empty EVA Bag?
Empty EVA Bag is manufactured by Haemotronic S.P.A..
What is the FDA product code for Empty EVA Bag?
The FDA product code for Empty EVA Bag is KPE.
Other Devices by Haemotronic S.P.A.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.