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FDA 510(k)

REXLON, REXSIL

K-Number: K161633 · 2017-03-02

ApplicantSm Eng Co., Ltd.
Decision Date2017-03-02
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REXLON, REXSIL is a medical device manufactured by Sm Eng Co., Ltd.. It received FDA 510(k) clearance on 2017-03-02 under approval number K161633. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REXLON, REXSIL?

REXLON, REXSIL is a medical device that received FDA 510(k) clearance on 2017-03-02. It is manufactured by Sm Eng Co., Ltd.. The 510(k) number is K161633.

When was REXLON, REXSIL approved by the FDA?

REXLON, REXSIL received FDA 510(k) clearance on 2017-03-02, under approval number K161633.

What company makes REXLON, REXSIL?

REXLON, REXSIL is manufactured by Sm Eng Co., Ltd..

What is the FDA product code for REXLON, REXSIL?

The FDA product code for REXLON, REXSIL is GAR.

Other Devices by Sm Eng Co., Ltd.

K161629CRYLREX K173747REXLENE 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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