MEDT PEN NEEDLE
K-Number: K152824 · 2016-03-07
Decision Date2016-03-07
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
MEDT PEN NEEDLE is a medical device manufactured by Shandong Caremed Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2016-03-07 under approval number K152824. 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 MEDT PEN NEEDLE?
MEDT PEN NEEDLE is a medical device that received FDA 510(k) clearance on 2016-03-07. It is manufactured by Shandong Caremed Medical Products Co., Ltd.. The 510(k) number is K152824.
When was MEDT PEN NEEDLE approved by the FDA?
MEDT PEN NEEDLE received FDA 510(k) clearance on 2016-03-07, under approval number K152824.
What company makes MEDT PEN NEEDLE?
MEDT PEN NEEDLE is manufactured by Shandong Caremed Medical Products Co., Ltd..
What is the FDA product code for MEDT PEN NEEDLE?
The FDA product code for MEDT 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.