HANAROCare ReJu
K-Number: K160893 · 2016-07-27
Device Summary
Frequently Asked Questions
What is the HANAROCare ReJu?
HANAROCare ReJu is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K160893.
When did HANAROCare ReJu receive FDA 510(k) clearance?
HANAROCare ReJu received FDA 510(k) clearance on 2016-07-27, under 510(k) number K160893.
Who is the listed applicant for HANAROCare ReJu?
The FDA 510(k) record lists M.I.Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HANAROCare ReJu?
The FDA product code for HANAROCare ReJu is NUH.
Other records listing M.I.Tech Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: NUH)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.