Extension Set
K-Number: K230528 · 2023-12-01
ApplicantMedcaptain Life Science Co., Ltd.
Decision Date2023-12-01
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Extension Set is a medical device manufactured by Medcaptain Life Science Co., Ltd.. It received FDA 510(k) clearance on 2023-12-01 under approval number K230528. 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 Extension Set?
Extension Set is a medical device that received FDA 510(k) clearance on 2023-12-01. It is manufactured by Medcaptain Life Science Co., Ltd.. The 510(k) number is K230528.
When was Extension Set approved by the FDA?
Extension Set received FDA 510(k) clearance on 2023-12-01, under approval number K230528.
What company makes Extension Set?
Extension Set is manufactured by Medcaptain Life Science Co., Ltd..
What is the FDA product code for Extension Set?
The FDA product code for Extension 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.