510(k) K180826
K180826 is an FDA 510(k) premarket notification submitted by Allergan for the device "Natrelle 133 Plus MICROCELL Tissue Expander". The FDA issued a decision of Substantially Equivalent on December 21, 2018. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Allergan has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2018
- Date Received
- March 30, 2018
- 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