Plasdent一次性屏障袖套和屏障膜
K号: K201604 · 2020-12-23
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决定日期2020-12-23
产品代码PEM
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Plasdent Disposable Barrier Sleeves and Barrier Film is the device name listed in this FDA 510(k) record. The listed applicant is Plasdent Corporation. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K201604. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Plasdent Disposable Barrier Sleeves and Barrier Film?
Plasdent Disposable Barrier Sleeves and Barrier Film is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Plasdent Corporation. The 510(k) number is K201604.
When did Plasdent Disposable Barrier Sleeves and Barrier Film receive FDA 510(k) clearance?
Plasdent Disposable Barrier Sleeves and Barrier Film received FDA 510(k) clearance on 2020-12-23, under 510(k) number K201604.
Who is the listed applicant for Plasdent Disposable Barrier Sleeves and Barrier Film?
The FDA 510(k) record lists Plasdent Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Plasdent Disposable Barrier Sleeves and Barrier Film?
The FDA product code for Plasdent Disposable Barrier Sleeves and Barrier Film is PEM.
相关临床试验
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相关器械（代码：PEM）
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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