510(k) K211676

Motiva Flora SmoothSilk Tissue Expander by Motiva USA, LLC — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2023
Date Received
June 1, 2021
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