510(k) K062720

S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES by Richard Wolf Medical Instruments Corp. — Product Code FJL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2007
Date Received
September 12, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resectoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type