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FDA 510(k)

Dual-Safety Pen Needle

K-Number: K191853 · 2019-09-05

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2019-09-05
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Dual-Safety Pen Needle is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2019-09-05 under approval number K191853. 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 Dual-Safety Pen Needle?

Dual-Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2019-09-05. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K191853.

When was Dual-Safety Pen Needle approved by the FDA?

Dual-Safety Pen Needle received FDA 510(k) clearance on 2019-09-05, under approval number K191853.

What company makes Dual-Safety Pen Needle?

Dual-Safety Pen Needle is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Dual-Safety Pen Needle?

The FDA product code for Dual-Safety Pen Needle is FMI.

Related Clinical Trials

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Related PubMed Literature

PMID: 30016051 General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device. Final order. Federal register (2018)

Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle K193009Promisemed Heel Blood Lancet K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet K202681Promisemed Covered Safety Pen Needle K202682Promisemed Triple Safety Pen Needle K211890Promisemed Sharps container

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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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