HydraDose 阴道栓剂
K号: K230518 · 2023-06-23
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申请人MD Labs, LLC
决定日期2023-06-23
产品代码NUC
咨询委员会OB
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决定实质等同
器械摘要
HydraDose Vaginal Suppositories is the device name listed in this FDA 510(k) record. The listed applicant is MD Labs, LLC. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K230518. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HydraDose Vaginal Suppositories?
HydraDose Vaginal Suppositories is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is MD Labs, LLC. The 510(k) number is K230518.
When did HydraDose Vaginal Suppositories receive FDA 510(k) clearance?
HydraDose Vaginal Suppositories received FDA 510(k) clearance on 2023-06-23, under 510(k) number K230518.
Who is the listed applicant for HydraDose Vaginal Suppositories?
The FDA 510(k) record lists MD Labs, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HydraDose Vaginal Suppositories?
The FDA product code for HydraDose Vaginal Suppositories is NUC.
相关临床试验
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相关器械（代码：NUC）
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。
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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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