510(k) K142998
K142998 is an FDA 510(k) premarket notification submitted by Mentor Worldwide, LLC for the device "CPX Control Breast Tissue Expander". The FDA issued a decision of Substantially Equivalent on December 19, 2014. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2014
- Date Received
- October 17, 2014
- Clearance Type
- Traditional
- 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