FDA 510(k)

Bausch + Lomb Boston 高级清洁剂，Bausch + Lomb Boston 高级护理液

K号: K180319 · 2018-03-27

决定日期2018-03-27

产品代码MRC

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决定实质等同

器械摘要

Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution is the device name listed in this FDA 510(k) record. The listed applicant is Bausch and Lomb, Incorporated. It received FDA 510(k) clearance on 2018-03-27 under 510(k) number K180319. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution?

Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution is a medical device that received FDA 510(k) clearance on 2018-03-27. The listed applicant is Bausch and Lomb, Incorporated. The 510(k) number is K180319.

When did Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution receive FDA 510(k) clearance?

Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution received FDA 510(k) clearance on 2018-03-27, under 510(k) number K180319.

Who is the listed applicant for Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution?

The FDA 510(k) record lists Bausch and Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution?

The FDA product code for Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution is MRC.

列明Bausch and Lomb, Incorporated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。

K252052Stellaris Elite™视觉增强系统(BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)K242389EyeGility™ Inserter for Preloaded enVista IOLs K240169Stellaris Elite视觉增强系统(BL11145, BL14455, BL15455)K220613Bausch + Lomb (kalifilcon A) 软性（亲水性）隐形眼镜，Bausch + Lomb (kalifilcon A) 软性（亲水性）散光隐形眼镜，以及，Bausch + Lomb (kalifilcon A) 软性（亲水性）老花隐形眼镜 K222541Bausch + Lomb 无防腐剂润滑和湿润滴眼液 K202932ABT12 多功能溶液

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官方来源

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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。