510(k) K212750

Ultrasonic Surgical Aspirator System, Model: XD880B by Smtp Technology Co., Ltd. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2021
Date Received
August 30, 2021
Clearance Type
Special
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