HyaloGYN 阴道保湿栓
K号: K191052 · 2020-01-09
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决定日期2020-01-09
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
HyaloGYN Vaginal Moisturizing Suppositories is the device name listed in this FDA 510(k) record. The listed applicant is Fidia Farmaceutici S.P.A.. It received FDA 510(k) clearance on 2020-01-09 under 510(k) number K191052. 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 HyaloGYN Vaginal Moisturizing Suppositories?
HyaloGYN Vaginal Moisturizing Suppositories is a medical device that received FDA 510(k) clearance on 2020-01-09. The listed applicant is Fidia Farmaceutici S.P.A.. The 510(k) number is K191052.
When did HyaloGYN Vaginal Moisturizing Suppositories receive FDA 510(k) clearance?
HyaloGYN Vaginal Moisturizing Suppositories received FDA 510(k) clearance on 2020-01-09, under 510(k) number K191052.
Who is the listed applicant for HyaloGYN Vaginal Moisturizing Suppositories?
The FDA 510(k) record lists Fidia Farmaceutici S.P.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HyaloGYN Vaginal Moisturizing Suppositories?
The FDA product code for HyaloGYN Vaginal Moisturizing Suppositories is NUC.
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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
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