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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 a medical device manufactured by Nbc Meshtec, Inc.. It received FDA 510(k) clearance on 2019-01-03 under approval 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. It is manufactured by Nbc Meshtec, Inc.. The 510(k) number is K182766.

When was Cufitec Surgical Mask approved by the FDA?

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

What company makes Cufitec Surgical Mask?

Cufitec Surgical Mask is manufactured by Nbc Meshtec, Inc..

What is the FDA product code for Cufitec Surgical Mask?

The FDA product code for Cufitec Surgical Mask is OUK.

Related Devices (Code: OUK)

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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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