FDA 510(k)

Pac-Dent 障碍袖套，Cover-It™ 障碍薄膜

K号: K151123 · 2016-03-03

决定日期2016-03-03

产品代码PEM

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决定实质等同

器械摘要

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent International, Inc.. It received FDA 510(k) clearance on 2016-03-03 under 510(k) number K151123. 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 Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film?

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Pac-Dent International, Inc.. The 510(k) number is K151123.

When did Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film receive FDA 510(k) clearance?

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film received FDA 510(k) clearance on 2016-03-03, under 510(k) number K151123.

Who is the listed applicant for Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film?

The FDA 510(k) record lists Pac-Dent International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film?

The FDA product code for Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film is PEM.

列明Pac-Dent International, Inc.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。

K162662GingiDent 牙龈退缩膏 K160577PacEndo 氯己定 K153528PacEndo EDTA

官方来源

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