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FDA 510(k)

DemeMASK

K-Number: K201479 · 2020-07-24

ApplicantDemetech Corporation
Decision Date2020-07-24
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DemeMASK is the device name listed in this FDA 510(k) record. The listed applicant is Demetech Corporation. It received FDA 510(k) clearance on 2020-07-24 under 510(k) number K201479. 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 DemeMASK?

DemeMASK is a medical device that received FDA 510(k) clearance on 2020-07-24. The listed applicant is Demetech Corporation. The 510(k) number is K201479.

When did DemeMASK receive FDA 510(k) clearance?

DemeMASK received FDA 510(k) clearance on 2020-07-24, under 510(k) number K201479.

Who is the listed applicant for DemeMASK?

The FDA 510(k) record lists Demetech Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DemeMASK?

The FDA product code for DemeMASK is FXX.

Other records listing Demetech Corporation 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.

K191361DemeDIOX Barbed Absorbable Surgical SutureK190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureK181578DemeTECH PTFE Nonabsorbable Surgical SutureK181582DemeTECH DemeDIOX absorbable surgical suture

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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