Comfort Guard Mask, level 1, Comfort Guard Mask, level 3

FDA 510(k) K210860 · Gri-Alleset, Inc.

Substantially Equivalent

510(k) numberK210860

Submission

Device name
Comfort Guard Mask, level 1, Comfort Guard Mask, level 3
Applicant
Gri-Alleset, Inc.
Flowery Branch, GA, US
Received
March 23, 2021
Decision date
April 7, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FXX – Mask, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4040
Specialty
General, Plastic Surgery

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Questions and answers

When was Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 cleared by the FDA?

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 (K210860) received a 510(k) decision of Substantially Equivalent on April 7, 2022, 380 days after the submission was received.

What is the product code of K210860?

The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.