510(k) K011911

SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX by Richard Wolf Medical Instruments Corp. — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2001
Date Received
June 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Electro-Hydraulic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type