510(k) K091511

MODERN MEDICAL RESECTOSCOPE ELECTRODES by Modern Medical Equipment Mfg., Ltd. — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2010
Date Received
May 22, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical, Active, Urological
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type