FDA 510(k)

BH Medical Dental Barrier Sleeves and Barrier Film

K号: K190484 · 2019-09-10

决定日期2019-09-10

产品代码PEM

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决定实质等同

器械摘要

BH Medical Dental Barrier Sleeves and Barrier Film is the device name listed in this FDA 510(k) record. The listed applicant is Bh Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2019-09-10 under 510(k) number K190484. 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 BH Medical Dental Barrier Sleeves and Barrier Film?

BH Medical Dental Barrier Sleeves and Barrier Film is a medical device that received FDA 510(k) clearance on 2019-09-10. The listed applicant is Bh Medical Products Co., Ltd.. The 510(k) number is K190484.

When did BH Medical Dental Barrier Sleeves and Barrier Film receive FDA 510(k) clearance?

BH Medical Dental Barrier Sleeves and Barrier Film received FDA 510(k) clearance on 2019-09-10, under 510(k) number K190484.

Who is the listed applicant for BH Medical Dental Barrier Sleeves and Barrier Film?

The FDA 510(k) record lists Bh Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BH Medical Dental Barrier Sleeves and Barrier Film?

The FDA product code for BH Medical Dental Barrier Sleeves and Barrier Film is PEM.

列明Bh Medical Products Co., Ltd.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。

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