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FDA 510(k)

SURGICAL MASK, Model Name:C015

K-Number: K210218 · 2021-05-07

ApplicantQingdao Hainuo Biological Engineering Co., Ltd.
Decision Date2021-05-07
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL MASK, Model Name:C015 is a medical device manufactured by Qingdao Hainuo Biological Engineering Co., Ltd.. It received FDA 510(k) clearance on 2021-05-07 under approval number K210218. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL MASK, Model Name:C015?

SURGICAL MASK, Model Name:C015 is a medical device that received FDA 510(k) clearance on 2021-05-07. It is manufactured by Qingdao Hainuo Biological Engineering Co., Ltd.. The 510(k) number is K210218.

When was SURGICAL MASK, Model Name:C015 approved by the FDA?

SURGICAL MASK, Model Name:C015 received FDA 510(k) clearance on 2021-05-07, under approval number K210218.

What company makes SURGICAL MASK, Model Name:C015?

SURGICAL MASK, Model Name:C015 is manufactured by Qingdao Hainuo Biological Engineering Co., Ltd..

What is the FDA product code for SURGICAL MASK, Model Name:C015?

The FDA product code for SURGICAL MASK, Model Name:C015 is FXX.

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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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