HANAROCare ReJu
K-Number: K160893 · 2016-07-27
ApplicantM.I.Tech Co., Ltd.
Decision Date2016-07-27
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
HANAROCare ReJu is a medical device manufactured by M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2016-07-27 under approval number K160893. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HANAROCare ReJu?
HANAROCare ReJu is a medical device that received FDA 510(k) clearance on 2016-07-27. It is manufactured by M.I.Tech Co., Ltd.. The 510(k) number is K160893.
When was HANAROCare ReJu approved by the FDA?
HANAROCare ReJu received FDA 510(k) clearance on 2016-07-27, under approval number K160893.
What company makes HANAROCare ReJu?
HANAROCare ReJu is manufactured by M.I.Tech Co., Ltd..
What is the FDA product code for HANAROCare ReJu?
The FDA product code for HANAROCare ReJu is NUH.
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K201342HANAROSTENT Trachea/Bronchium (CCC)
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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.