510(k) K880166

BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 by Clinical Technology Corp. — Product Code LFL

K880166 is an FDA 510(k) premarket notification submitted by Clinical Technology Corp. for the device "BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000". The FDA issued a decision of Substantially Equivalent on February 18, 1988. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Clinical Technology Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1988
Date Received
January 14, 1988
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