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FDA 510(k)

Medical Surgical Masks-Non Sterile

K-Number: K202594 · 2021-01-06

Decision Date2021-01-06
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Surgical Masks-Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Shandong T&F Nonwoven Co., Ltd.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K202594. 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 Masks-Non Sterile?

Medical Surgical Masks-Non Sterile is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Shandong T&F Nonwoven Co., Ltd.. The 510(k) number is K202594.

When did Medical Surgical Masks-Non Sterile receive FDA 510(k) clearance?

Medical Surgical Masks-Non Sterile received FDA 510(k) clearance on 2021-01-06, under 510(k) number K202594.

Who is the listed applicant for Medical Surgical Masks-Non Sterile?

The FDA 510(k) record lists Shandong T&F Nonwoven Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Surgical Masks-Non Sterile?

The FDA product code for Medical Surgical Masks-Non Sterile is FXX.

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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