Smoklean
K-Number: K173108 · 2018-05-18
ApplicantSejong Medical Co., Ltd.
Decision Date2018-05-18
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Smoklean is a medical device manufactured by Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-05-18 under approval number K173108. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Smoklean?
Smoklean is a medical device that received FDA 510(k) clearance on 2018-05-18. It is manufactured by Sejong Medical Co., Ltd.. The 510(k) number is K173108.
When was Smoklean approved by the FDA?
Smoklean received FDA 510(k) clearance on 2018-05-18, under approval number K173108.
What company makes Smoklean?
Smoklean is manufactured by Sejong Medical Co., Ltd..
What is the FDA product code for Smoklean?
The FDA product code for Smoklean is FYD.
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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.