Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel
K-Number: K171144 · 2017-09-12
ApplicantMedbio, LLC
Decision Date2017-09-12
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 Medbio, LLC. It received FDA 510(k) clearance on 2017-09-12 under approval number K171144. 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 2017-09-12. It is manufactured by Medbio, LLC. The 510(k) number is K171144.
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 2017-09-12, under approval number K171144.
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 Medbio, 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.