Repagyn 阴道栓剂
K号: K153372 · 2016-06-30
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决定日期2016-06-30
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
Repagyn vaginal suppositories is the device name listed in this FDA 510(k) record. The listed applicant is Farma-Derma S.R.L.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K153372. 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 Repagyn vaginal suppositories?
Repagyn vaginal suppositories is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Farma-Derma S.R.L.. The 510(k) number is K153372.
When did Repagyn vaginal suppositories receive FDA 510(k) clearance?
Repagyn vaginal suppositories received FDA 510(k) clearance on 2016-06-30, under 510(k) number K153372.
Who is the listed applicant for Repagyn vaginal suppositories?
The FDA 510(k) record lists Farma-Derma S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Repagyn vaginal suppositories?
The FDA product code for Repagyn vaginal suppositories is NUC.
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Farma-Derma S.R.L.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。
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。
K260117EverslideSpecial Situations, LLCK253989HARU Orgasm 杰克·赫尔水基润滑剂（WL-OJ）；HARU Orgasm 水基润滑剂（WL-OR）；HARU STEAMY 水基润滑剂（WL-ST）Maxigen Biotech, Inc.K261905BUM油Bumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP水基个人润滑剂和保湿剂PINKSLIP, LLCK261909Plum Vagiceuticals® 阴道保湿栓PCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.
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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