FDA 510(k)

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix

Número K: K183163 · 2019-02-05

Data da decisão2019-02-05

Código do produtoMRD

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Motiva USA, LLC como candidato(a)

K211676Motiva Flora SmoothSilk Tissue Expander

Dispositivos Relacionados (Código: MRD)

K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC K203229NATRELLE INSPIRA Single Use Sizers for Gel ImplantsAllergan K200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc.

Fonte oficial

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