510(k) K130813

MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS by Mentor Corp. — Product Code LCJ

K130813 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS". The FDA issued a decision of Substantially Equivalent on April 11, 2013. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Mentor Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2013
Date Received
March 25, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type