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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 the device name listed in this FDA 510(k) record. The listed applicant is Sm Eng Co., Ltd.. It received FDA 510(k) clearance on 2017-03-02 under 510(k) 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. The listed applicant is Sm Eng Co., Ltd.. The 510(k) number is K161633.

When did REXLON, REXSIL receive FDA 510(k) clearance?

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

Who is the listed applicant for REXLON, REXSIL?

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

What is the FDA product code for REXLON, REXSIL?

The FDA product code for REXLON, REXSIL is GAR.

Other records listing Sm Eng 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.

K200392REXSINK173747REXLENEK173779REXMONO, PDREXK161629CRYLREX

Related Devices (Code: GAR)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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