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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 the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent, Inc.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) 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. The listed applicant is Pac-Dent, Inc.. The 510(k) number is K201182.

When did iMask Disposable Surgical Face Mask receive FDA 510(k) clearance?

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

Who is the listed applicant for iMask Disposable Surgical Face Mask?

The FDA 510(k) record lists Pac-Dent, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Pac-Dent, Inc. as applicant

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Related Devices (Code: FXX)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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