510(k) K023468

ENDOSCOPIC LIGHT SOURCE XL180/L3 by World of Medicine Lemke GmbH — Product Code GCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2003
Date Received
October 16, 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