ProSeal Closed System Administration Set
K-Number: K230343 · 2023-11-03
ApplicantEpic Medical Pte. , Ltd.
Decision Date2023-11-03
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
ProSeal Closed System Administration Set is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2023-11-03 under approval number K230343. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ProSeal Closed System Administration Set?
ProSeal Closed System Administration Set is a medical device that received FDA 510(k) clearance on 2023-11-03. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K230343.
When was ProSeal Closed System Administration Set approved by the FDA?
ProSeal Closed System Administration Set received FDA 510(k) clearance on 2023-11-03, under approval number K230343.
What company makes ProSeal Closed System Administration Set?
ProSeal Closed System Administration Set is manufactured by Epic Medical Pte. , Ltd..
What is the FDA product code for ProSeal Closed System Administration Set?
The FDA product code for ProSeal Closed System Administration Set is FPA.
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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.