510(k) K182335

CPX 4 Breast Tissue Expander with Smooth Surface by Mentor Worldwide, LLC — Product Code LCJ

K182335 is an FDA 510(k) premarket notification submitted by Mentor Worldwide, LLC for the device "CPX 4 Breast Tissue Expander with Smooth Surface". The FDA issued a decision of Substantially Equivalent on September 25, 2018. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Mentor Worldwide, LLC has at least 10 other 510(k) clearances on record.