510(k) K182054

Natrelle 133S Tissue Expander by Allergan — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2018
Date Received
July 31, 2018
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