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FDA 510(k)

Promisemed Triple Safety Pen Needle

K-Number: K202682 · 2020-11-24

Decision Date2020-11-24
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Promisemed Triple Safety Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2020-11-24 under 510(k) number K202682. 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 Promisemed Triple Safety Pen Needle?

Promisemed Triple Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2020-11-24. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K202682.

When did Promisemed Triple Safety Pen Needle receive FDA 510(k) clearance?

Promisemed Triple Safety Pen Needle received FDA 510(k) clearance on 2020-11-24, under 510(k) number K202682.

Who is the listed applicant for Promisemed Triple Safety Pen Needle?

The FDA 510(k) record lists Promisemed Hangzhou Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Promisemed Triple Safety Pen Needle?

The FDA product code for Promisemed Triple Safety Pen Needle is FMI.

Other records listing Promisemed Hangzhou Meditech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 35 devices →

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.