FDA 510(k)

MISTI 硅胶植入物

K号: K241150 · 2024-07-24

决定日期2024-07-24

产品代码MIB

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决定实质等同

器械摘要

MISTI Silicone Implant is the device name listed in this FDA 510(k) record. The listed applicant is Keosan Trading Co.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K241150. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MISTI Silicone Implant?

MISTI Silicone Implant is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Keosan Trading Co.. The 510(k) number is K241150.

When did MISTI Silicone Implant receive FDA 510(k) clearance?

MISTI Silicone Implant received FDA 510(k) clearance on 2024-07-24, under 510(k) number K241150.

Who is the listed applicant for MISTI Silicone Implant?

The FDA 510(k) record lists Keosan Trading Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MISTI Silicone Implant?

The FDA product code for MISTI Silicone Implant is MIB.

列明Keosan Trading Co.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。

K232593FITme 定制硅胶植入物

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。