510(k) K020889

ENDOSCOPIC LIGHT SOURCE XL202/L3 by World of Medicine Lemke GmbH — Product Code GCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2002
Date Received
March 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Endoscope, Xenon Arc
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type