510(k) K873367

OLYMPUS LUS ULTRASONIC LITHOTRIPTER by Olympus Corp. — Product Code FEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1987
Date Received
August 21, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Ultrasonic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type