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FDA 510(k)

REXLENE

K-Number: K173747 · 2018-12-21

ApplicantSm Eng Co., Ltd.
Decision Date2018-12-21
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REXLENE is a medical device manufactured by Sm Eng Co., Ltd.. It received FDA 510(k) clearance on 2018-12-21 under approval number K173747. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REXLENE?

REXLENE is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Sm Eng Co., Ltd.. The 510(k) number is K173747.

When was REXLENE approved by the FDA?

REXLENE received FDA 510(k) clearance on 2018-12-21, under approval number K173747.

What company makes REXLENE?

REXLENE is manufactured by Sm Eng Co., Ltd..

What is the FDA product code for REXLENE?

The FDA product code for REXLENE is GAW.

Other Devices by Sm Eng Co., Ltd.

K161633REXLON, REXSIL K161629CRYLREX K173779REXMONO, PDREX K200392REXSIN

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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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