FDA 510(k)

一次性、无菌、硅胶乳房测量器Motiva植入矩阵

K号: K183163 · 2019-02-05

决定日期2019-02-05

产品代码MRD

决定Substantially Equivalent

器械摘要

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Motiva USA, LLC. It received FDA 510(k) clearance on 2019-02-05 under 510(k) number K183163. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

常见问题

What is the Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix?

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix is a medical device that received FDA 510(k) clearance on 2019-02-05. The listed applicant is Motiva USA, LLC. The 510(k) number is K183163.

When did Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix receive FDA 510(k) clearance?

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix received FDA 510(k) clearance on 2019-02-05, under 510(k) number K183163.

Who is the listed applicant for Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix?

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

What is the FDA product code for Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix?

The FDA product code for Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix is MRD.

列明Motiva USA, LLC为申报人的其他记录

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