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FDA 510(k)

Master-Frank N95 Particulate Respirator

K-Number: K172963 · 2018-04-04

ApplicantMaster & Frank Enterprise Co., Ltd.
Decision Date2018-04-04
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Master-Frank N95 Particulate Respirator is a medical device manufactured by Master & Frank Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2018-04-04 under approval number K172963. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Master-Frank N95 Particulate Respirator?

Master-Frank N95 Particulate Respirator is a medical device that received FDA 510(k) clearance on 2018-04-04. It is manufactured by Master & Frank Enterprise Co., Ltd.. The 510(k) number is K172963.

When was Master-Frank N95 Particulate Respirator approved by the FDA?

Master-Frank N95 Particulate Respirator received FDA 510(k) clearance on 2018-04-04, under approval number K172963.

What company makes Master-Frank N95 Particulate Respirator?

Master-Frank N95 Particulate Respirator is manufactured by Master & Frank Enterprise Co., Ltd..

What is the FDA product code for Master-Frank N95 Particulate Respirator?

The FDA product code for Master-Frank N95 Particulate Respirator is MSH.

Related Devices (Code: MSH)

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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.

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