SurgiMend PRS Meshed, Revize-X
K号: K171357 · 2017-06-07
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决定日期2017-06-07
产品代码OXH
咨询委员会SU
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器械摘要
SurgiMend PRS Meshed, Revize-X is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corporation (Owner of Tei Biosciences). It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K171357. The device is classified under product code OXH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SurgiMend PRS Meshed, Revize-X?
SurgiMend PRS Meshed, Revize-X is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Integra Lifesciences Corporation (Owner of Tei Biosciences). The 510(k) number is K171357.
When did SurgiMend PRS Meshed, Revize-X receive FDA 510(k) clearance?
SurgiMend PRS Meshed, Revize-X received FDA 510(k) clearance on 2017-06-07, under 510(k) number K171357.
Who is the listed applicant for SurgiMend PRS Meshed, Revize-X?
The FDA 510(k) record lists Integra Lifesciences Corporation (Owner of Tei Biosciences) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SurgiMend PRS Meshed, Revize-X?
The FDA product code for SurgiMend PRS Meshed, Revize-X is OXH.
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相关器械（代码：OXH）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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