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FDA 510(k)

Medical Surgical Mask

K-Number: K202029 · 2020-12-16

ApplicantBeijing Biosis Healing Biolog Ical Technology Co., Ltd.
Decision Date2020-12-16
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-12-16 under 510(k) number K202029. 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 Medical Surgical Mask?

Medical Surgical Mask is a medical device that received FDA 510(k) clearance on 2020-12-16. The listed applicant is Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. The 510(k) number is K202029.

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

Medical Surgical Mask received FDA 510(k) clearance on 2020-12-16, under 510(k) number K202029.

Who is the listed applicant for Medical Surgical Mask?

The FDA 510(k) record lists Beijing Biosis Healing Biolog Ical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Surgical Mask?

The FDA product code for Medical Surgical Mask is FXX.

Other records listing Beijing Biosis Healing Biolog Ical Technology Co., Ltd. as applicant

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Related Devices (Code: FXX)

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.

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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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