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FDA 510(k)

Surgical 3D Mask

K-Number: K203565 · 2021-10-19

ApplicantInno Lifecare
Decision Date2021-10-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical 3D Mask is a medical device manufactured by Inno Lifecare. It received FDA 510(k) clearance on 2021-10-19 under approval number K203565. 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 3D Mask?

Surgical 3D Mask is a medical device that received FDA 510(k) clearance on 2021-10-19. It is manufactured by Inno Lifecare. The 510(k) number is K203565.

When was Surgical 3D Mask approved by the FDA?

Surgical 3D Mask received FDA 510(k) clearance on 2021-10-19, under approval number K203565.

What company makes Surgical 3D Mask?

Surgical 3D Mask is manufactured by Inno Lifecare.

What is the FDA product code for Surgical 3D Mask?

The FDA product code for Surgical 3D Mask is FXX.

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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