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FDA 510(k)

Surgical Mask-Models CR02-2, CR02

K-Number: K202424 · 2021-03-31

ApplicantFoshan Xinbao Technology Co., Ltd.
Decision Date2021-03-31
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Mask-Models CR02-2, CR02 is a medical device manufactured by Foshan Xinbao Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-03-31 under approval number K202424. 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-Models CR02-2, CR02?

Surgical Mask-Models CR02-2, CR02 is a medical device that received FDA 510(k) clearance on 2021-03-31. It is manufactured by Foshan Xinbao Technology Co., Ltd.. The 510(k) number is K202424.

When was Surgical Mask-Models CR02-2, CR02 approved by the FDA?

Surgical Mask-Models CR02-2, CR02 received FDA 510(k) clearance on 2021-03-31, under approval number K202424.

What company makes Surgical Mask-Models CR02-2, CR02?

Surgical Mask-Models CR02-2, CR02 is manufactured by Foshan Xinbao Technology Co., Ltd..

What is the FDA product code for Surgical Mask-Models CR02-2, CR02?

The FDA product code for Surgical Mask-Models CR02-2, CR02 is FXX.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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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