510(k) K182809

CUSA Clarity Ultrasonic Surgical Aspirator System by Integra LifeSciences Corporation — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2018
Date Received
October 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type