510(k) K151055

Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE by Mentor Worldwide, LLC — Product Code MRD

K151055 is an FDA 510(k) premarket notification submitted by Mentor Worldwide, LLC for the device "Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE". The FDA issued a decision of Substantially Equivalent on May 20, 2015. The device falls under product code MRD (Mammary Sizer), a Class U device. Mentor Worldwide, LLC has at least 10 other 510(k) clearances on record.