Allura阴道支架
K号: K202542 · 2020-09-30
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决定日期2020-09-30
产品代码KXP
咨询委员会OB
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Allura Vaginal Stent is the device name listed in this FDA 510(k) record. The listed applicant is Pmt Corporation. It received FDA 510(k) clearance on 2020-09-30 under 510(k) number K202542. The device is classified under product code KXP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Allura Vaginal Stent?
Allura Vaginal Stent is a medical device that received FDA 510(k) clearance on 2020-09-30. The listed applicant is Pmt Corporation. The 510(k) number is K202542.
When did Allura Vaginal Stent receive FDA 510(k) clearance?
Allura Vaginal Stent received FDA 510(k) clearance on 2020-09-30, under 510(k) number K202542.
Who is the listed applicant for Allura Vaginal Stent?
The FDA 510(k) record lists Pmt Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Allura Vaginal Stent?
The FDA product code for Allura Vaginal Stent is KXP.
相关临床试验
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。
列明Pmt Corporation为申报人的其他记录
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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