FDA 510(k)

Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3

Numéro K : K211066 · 2021-08-19

Date de décision2021-08-19

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 is the device name listed in this FDA 510(k) record. The listed applicant is Homtex, Inc.. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K211066. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3?

Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Homtex, Inc.. The 510(k) number is K211066.

When did Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 receive FDA 510(k) clearance?

Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 received FDA 510(k) clearance on 2021-08-19, under 510(k) number K211066.

Who is the listed applicant for Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3?

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

What is the FDA product code for Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3?

The FDA product code for Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 is FXX.

Essais cliniques associés

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Autres dossiers indiquant Homtex, Inc. en tant que demandeur

K201095Sovereign America Surgical Face Mask

Dispositifs connexes (Code : FXX)

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.

Source officielle

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