SURGICAL ISOLATION GOWN
K-Number: K171535 · 2018-02-15
Decision Date2018-02-15
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SURGICAL ISOLATION GOWN is a medical device manufactured by Jingzhou Haixin Green Cross Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2018-02-15 under approval number K171535. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SURGICAL ISOLATION GOWN?
SURGICAL ISOLATION GOWN is a medical device that received FDA 510(k) clearance on 2018-02-15. It is manufactured by Jingzhou Haixin Green Cross Medical Products Co., Ltd.. The 510(k) number is K171535.
When was SURGICAL ISOLATION GOWN approved by the FDA?
SURGICAL ISOLATION GOWN received FDA 510(k) clearance on 2018-02-15, under approval number K171535.
What company makes SURGICAL ISOLATION GOWN?
SURGICAL ISOLATION GOWN is manufactured by Jingzhou Haixin Green Cross Medical Products Co., Ltd..
What is the FDA product code for SURGICAL ISOLATION GOWN?
The FDA product code for SURGICAL ISOLATION GOWN is FYC.
Other Devices by Jingzhou Haixin Green Cross Medical Products Co., Ltd.
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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.