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FDA 510(k)

SURGICAL GOWN, SMS

K-Number: K121152 · 2012-12-12

ApplicantJiangsu Guangda Medical Material, Co., Ltd.
Decision Date2012-12-12
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL GOWN, SMS is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Guangda Medical Material, Co., Ltd.. It received FDA 510(k) clearance on 2012-12-12 under 510(k) number K121152. 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 SURGICAL GOWN, SMS?

SURGICAL GOWN, SMS is a medical device that received FDA 510(k) clearance on 2012-12-12. The listed applicant is Jiangsu Guangda Medical Material, Co., Ltd.. The 510(k) number is K121152.

When did SURGICAL GOWN, SMS receive FDA 510(k) clearance?

SURGICAL GOWN, SMS received FDA 510(k) clearance on 2012-12-12, under 510(k) number K121152.

Who is the listed applicant for SURGICAL GOWN, SMS?

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

What is the FDA product code for SURGICAL GOWN, SMS?

The FDA product code for SURGICAL GOWN, SMS is FYA.

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Related Devices (Code: 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.

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