Harmony乳胶阻隔器，Harmony非乳胶阻隔器
K号: K203727 · 2021-08-05
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决定日期2021-08-05
产品代码MSC
咨询委员会OB
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决定实质等同
器械摘要
Harmony Latex Dam, Harmony Non-Latex Dam is the device name listed in this FDA 510(k) record. The listed applicant is Pamco Distributing, Inc.. It received FDA 510(k) clearance on 2021-08-05 under 510(k) number K203727. The device is classified under product code MSC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Harmony Latex Dam, Harmony Non-Latex Dam?
Harmony Latex Dam, Harmony Non-Latex Dam is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Pamco Distributing, Inc.. The 510(k) number is K203727.
When did Harmony Latex Dam, Harmony Non-Latex Dam receive FDA 510(k) clearance?
Harmony Latex Dam, Harmony Non-Latex Dam received FDA 510(k) clearance on 2021-08-05, under 510(k) number K203727.
Who is the listed applicant for Harmony Latex Dam, Harmony Non-Latex Dam?
The FDA 510(k) record lists Pamco Distributing, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Harmony Latex Dam, Harmony Non-Latex Dam?
The FDA product code for Harmony Latex Dam, Harmony Non-Latex Dam is MSC.
相关临床试验
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相关器械（代码：MSC）
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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