FDA 510(k)

Avologi 凝胶底漆（型号：Av25）

K号: K220735 · 2023-09-15

决定日期2023-09-15

产品代码GYB

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决定实质等同

器械摘要

Avologi Gel Primer (Model: Av25) is the device name listed in this FDA 510(k) record. The listed applicant is Premier North America, Inc.. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K220735. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Avologi Gel Primer (Model: Av25)?

Avologi Gel Primer (Model: Av25) is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is Premier North America, Inc.. The 510(k) number is K220735.

When did Avologi Gel Primer (Model: Av25) receive FDA 510(k) clearance?

Avologi Gel Primer (Model: Av25) received FDA 510(k) clearance on 2023-09-15, under 510(k) number K220735.

Who is the listed applicant for Avologi Gel Primer (Model: Av25)?

The FDA 510(k) record lists Premier North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avologi Gel Primer (Model: Av25)?

The FDA product code for Avologi Gel Primer (Model: Av25) is GYB.

列明Premier North America, 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。

K233862NUNA LUX (NUNL528)K232656BLU TOTALE (型号：ENEOB852)K214100Luminice K213841ENEO TOTALE (型号：ENEO T947)K181659Avologi ENEO

官方来源

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