FDA 510(k)

SEJONG Surgical Gown Soft

K-Number: K220435 · 2023-02-10

Decision Date2023-02-10

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SEJONG Surgical Gown Soft is a medical device manufactured by Sejong Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2023-02-10 under approval number K220435. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEJONG Surgical Gown Soft?

SEJONG Surgical Gown Soft is a medical device that received FDA 510(k) clearance on 2023-02-10. It is manufactured by Sejong Healthcare Co., Ltd.. The 510(k) number is K220435.

When was SEJONG Surgical Gown Soft approved by the FDA?

SEJONG Surgical Gown Soft received FDA 510(k) clearance on 2023-02-10, under approval number K220435.

What company makes SEJONG Surgical Gown Soft?

SEJONG Surgical Gown Soft is manufactured by Sejong Healthcare Co., Ltd..

What is the FDA product code for SEJONG Surgical Gown Soft?

The FDA product code for SEJONG Surgical Gown Soft is FYA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.