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FDA 510(k)

Medical Face Mask

K-Number: K201629 · 2020-12-14

Decision Date2020-12-14
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Shengquan New Material Co., Ltd.. It received FDA 510(k) clearance on 2020-12-14 under 510(k) number K201629. 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 Face Mask?

Medical Face Mask is a medical device that received FDA 510(k) clearance on 2020-12-14. The listed applicant is Shandong Shengquan New Material Co., Ltd.. The 510(k) number is K201629.

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

Medical Face Mask received FDA 510(k) clearance on 2020-12-14, under 510(k) number K201629.

Who is the listed applicant for Medical Face Mask?

The FDA 510(k) record lists Shandong Shengquan New Material Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Face Mask?

The FDA product code for Medical Face Mask is FXX.

Other records listing Shandong Shengquan New Material Co., Ltd. as applicant

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.

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.

Official Source

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