FDA 510(k)

Sientra OPUS 硅胶乳房假体测量器

K号: K200706 · 2020-11-16

决定日期2020-11-16

产品代码MRD

决定实质等同

器械摘要

Sientra OPUS Silicone Gel Breast Implant Sizer is the device name listed in this FDA 510(k) record. The listed applicant is Sientra, Inc.. It received FDA 510(k) clearance on 2020-11-16 under 510(k) number K200706. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

常见问题

What is the Sientra OPUS Silicone Gel Breast Implant Sizer?

Sientra OPUS Silicone Gel Breast Implant Sizer is a medical device that received FDA 510(k) clearance on 2020-11-16. The listed applicant is Sientra, Inc.. The 510(k) number is K200706.

When did Sientra OPUS Silicone Gel Breast Implant Sizer receive FDA 510(k) clearance?

Sientra OPUS Silicone Gel Breast Implant Sizer received FDA 510(k) clearance on 2020-11-16, under 510(k) number K200706.

Who is the listed applicant for Sientra OPUS Silicone Gel Breast Implant Sizer?

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

What is the FDA product code for Sientra OPUS Silicone Gel Breast Implant Sizer?

The FDA product code for Sientra OPUS Silicone Gel Breast Implant Sizer is MRD.

列明Sientra, 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。

K214124AlloX2 Pro组织扩张器 K221127Sientra, inc. Portfinder

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