Top Fine Pen Needle
K-Number: K152410 · 2016-02-02
ApplicantMedexel Co.,Ltd
Decision Date2016-02-02
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Top Fine Pen Needle is a medical device manufactured by Medexel Co.,Ltd. It received FDA 510(k) clearance on 2016-02-02 under approval number K152410. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Top Fine Pen Needle?
Top Fine Pen Needle is a medical device that received FDA 510(k) clearance on 2016-02-02. It is manufactured by Medexel Co.,Ltd. The 510(k) number is K152410.
When was Top Fine Pen Needle approved by the FDA?
Top Fine Pen Needle received FDA 510(k) clearance on 2016-02-02, under approval number K152410.
What company makes Top Fine Pen Needle?
Top Fine Pen Needle is manufactured by Medexel Co.,Ltd.
What is the FDA product code for Top Fine Pen Needle?
The FDA product code for Top Fine Pen Needle is FMI.
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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.