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FDA 510(k)

Communicator Surgical Facemask with Clear Window

K-Number: K152561 · 2016-06-03

ApplicantPrestige Ameritech , Ltd.
Decision Date2016-06-03
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Communicator Surgical Facemask with Clear Window is a medical device manufactured by Prestige Ameritech , Ltd.. It received FDA 510(k) clearance on 2016-06-03 under approval number K152561. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Communicator Surgical Facemask with Clear Window?

Communicator Surgical Facemask with Clear Window is a medical device that received FDA 510(k) clearance on 2016-06-03. It is manufactured by Prestige Ameritech , Ltd.. The 510(k) number is K152561.

When was Communicator Surgical Facemask with Clear Window approved by the FDA?

Communicator Surgical Facemask with Clear Window received FDA 510(k) clearance on 2016-06-03, under approval number K152561.

What company makes Communicator Surgical Facemask with Clear Window?

Communicator Surgical Facemask with Clear Window is manufactured by Prestige Ameritech , Ltd..

What is the FDA product code for Communicator Surgical Facemask with Clear Window?

The FDA product code for Communicator Surgical Facemask with Clear Window is FXX.

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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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