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FDA 510(k)

Cufitec Surgical Mask

K-Number: K182766 · 2019-01-03

ApplicantNbc Meshtec, Inc.
Decision Date2019-01-03
Product CodeOUK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cufitec Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Nbc Meshtec, Inc.. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K182766. 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 Cufitec Surgical Mask?

Cufitec Surgical Mask is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is Nbc Meshtec, Inc.. The 510(k) number is K182766.

When did Cufitec Surgical Mask receive FDA 510(k) clearance?

Cufitec Surgical Mask received FDA 510(k) clearance on 2019-01-03, under 510(k) number K182766.

Who is the listed applicant for Cufitec Surgical Mask?

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

What is the FDA product code for Cufitec Surgical Mask?

The FDA product code for Cufitec Surgical Mask is OUK.

Related Devices (Code: OUK)

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.

K231741ProGear® Surgical Mask with Oxafence®, Model AV82030Prestige AmeritechK192105Innonix Antiviral Child's Face MaskInnonix Technologies Limited

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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