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FDA 510(k)

iMask Disposable Surgical Face Mask

K-Number: K201182 · 2021-02-19

ApplicantPac-Dent, Inc.
Decision Date2021-02-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

iMask Disposable Surgical Face Mask is a medical device manufactured by Pac-Dent, Inc.. It received FDA 510(k) clearance on 2021-02-19 under approval number K201182. 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 iMask Disposable Surgical Face Mask?

iMask Disposable Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-02-19. It is manufactured by Pac-Dent, Inc.. The 510(k) number is K201182.

When was iMask Disposable Surgical Face Mask approved by the FDA?

iMask Disposable Surgical Face Mask received FDA 510(k) clearance on 2021-02-19, under approval number K201182.

What company makes iMask Disposable Surgical Face Mask?

iMask Disposable Surgical Face Mask is manufactured by Pac-Dent, Inc..

What is the FDA product code for iMask Disposable Surgical Face Mask?

The FDA product code for iMask Disposable Surgical Face Mask is FXX.

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Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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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