Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel
K-Number: K180720 · 2018-06-27
ApplicantMedibio USA, LLC
Decision Date2018-06-27
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel is a medical device manufactured by Medibio USA, LLC. It received FDA 510(k) clearance on 2018-06-27 under approval number K180720. 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 Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel?
Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel is a medical device that received FDA 510(k) clearance on 2018-06-27. It is manufactured by Medibio USA, LLC. The 510(k) number is K180720.
When was Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel approved by the FDA?
Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel received FDA 510(k) clearance on 2018-06-27, under approval number K180720.
What company makes Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel?
Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel is manufactured by Medibio USA, LLC.
What is the FDA product code for Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel?
The FDA product code for Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel 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.