FDA 510(k)

BL-Cart IOL 注射器

K号: K182965 · 2019-03-29

决定日期2019-03-29

产品代码MSS

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决定实质等同

器械摘要

BL-Cart IOL Delivery Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Ast Products, Inc.. It received FDA 510(k) clearance on 2019-03-29 under 510(k) number K182965. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BL-Cart IOL Delivery Cartridge?

BL-Cart IOL Delivery Cartridge is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is Ast Products, Inc.. The 510(k) number is K182965.

When did BL-Cart IOL Delivery Cartridge receive FDA 510(k) clearance?

BL-Cart IOL Delivery Cartridge received FDA 510(k) clearance on 2019-03-29, under 510(k) number K182965.

Who is the listed applicant for BL-Cart IOL Delivery Cartridge?

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

What is the FDA product code for BL-Cart IOL Delivery Cartridge?

The FDA product code for BL-Cart IOL Delivery Cartridge is MSS.

列明Ast Products, 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。

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官方来源

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