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FDA 510(k)

Droplet Pen Needle 30G & 33G

K-Number: K202340 · 2020-10-15

ApplicantHtl-Strefa S.A
Decision Date2020-10-15
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Droplet Pen Needle 30G & 33G is a medical device manufactured by Htl-Strefa S.A. It received FDA 510(k) clearance on 2020-10-15 under approval number K202340. 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 Droplet Pen Needle 30G & 33G?

Droplet Pen Needle 30G & 33G is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Htl-Strefa S.A. The 510(k) number is K202340.

When was Droplet Pen Needle 30G & 33G approved by the FDA?

Droplet Pen Needle 30G & 33G received FDA 510(k) clearance on 2020-10-15, under approval number K202340.

What company makes Droplet Pen Needle 30G & 33G?

Droplet Pen Needle 30G & 33G is manufactured by Htl-Strefa S.A.

What is the FDA product code for Droplet Pen Needle 30G & 33G?

The FDA product code for Droplet Pen Needle 30G & 33G is FMI.

Other Devices by Htl-Strefa S.A

K170988DropSafe Safety Pen Needle K171982DROPLET PEN NEEDLE K192082Droplet Pen Needle 34G K220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets K250016droplet® personal lancets

Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.

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.

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