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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2019-06-26 under 510(k) 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. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K190096.

When did R2GATE receive FDA 510(k) clearance?

R2GATE received FDA 510(k) clearance on 2019-06-26, under 510(k) number K190096.

Who is the listed applicant for R2GATE?

The FDA 510(k) record lists Megagen Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R2GATE?

The FDA product code for R2GATE is LLZ.

Other records listing Megagen Implant 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.

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Related Devices (Code: LLZ)

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.

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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.

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