R2GATE
K-Number: K190096 · 2019-06-26
ApplicantMegagen Implant Co., Ltd.
Decision Date2019-06-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
R2GATE is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2019-06-26 under approval number K190096. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the R2GATE?
R2GATE is a medical device that received FDA 510(k) clearance on 2019-06-26. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K190096.
When was R2GATE approved by the FDA?
R2GATE received FDA 510(k) clearance on 2019-06-26, under approval number K190096.
What company makes R2GATE?
R2GATE is manufactured by Megagen Implant Co., Ltd..
What is the FDA product code for R2GATE?
The FDA product code for R2GATE is LLZ.
Other Devices by Megagen Implant Co., Ltd.
Related Devices (Code: LLZ)
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.