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FDA 510(k)

ProGear® Surgical Mask with Oxafence®, Model AV82030

K-Number: K231741 · 2024-09-05

ApplicantPrestige Ameritech
Decision Date2024-09-05
Product CodeOUK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ProGear® Surgical Mask with Oxafence®, Model AV82030 is a medical device manufactured by Prestige Ameritech. It received FDA 510(k) clearance on 2024-09-05 under approval number K231741. The device is classified under product code OUK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProGear® Surgical Mask with Oxafence®, Model AV82030?

ProGear® Surgical Mask with Oxafence®, Model AV82030 is a medical device that received FDA 510(k) clearance on 2024-09-05. It is manufactured by Prestige Ameritech. The 510(k) number is K231741.

When was ProGear® Surgical Mask with Oxafence®, Model AV82030 approved by the FDA?

ProGear® Surgical Mask with Oxafence®, Model AV82030 received FDA 510(k) clearance on 2024-09-05, under approval number K231741.

What company makes ProGear® Surgical Mask with Oxafence®, Model AV82030?

ProGear® Surgical Mask with Oxafence®, Model AV82030 is manufactured by Prestige Ameritech.

What is the FDA product code for ProGear® Surgical Mask with Oxafence®, Model AV82030?

The FDA product code for ProGear® Surgical Mask with Oxafence®, Model AV82030 is OUK.

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Related PubMed Literature

PMID: 25646114 Transcatheter valve therapy registry is a model for medical device innovation and surveillance. Health affairs (Project Hope) (2015)

Other Devices by Prestige Ameritech

K160100Prestige Ameritech Pediatric/Child’s Face mask K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield

Related Devices (Code: OUK)

K192105Innonix Antiviral Child's Face MaskInnonix Technologies Limited K182766Cufitec Surgical MaskNbc Meshtec, Inc.

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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