510(k) K981804

XENON LIGHT SOURCE MODEL LS6000 by Contec Medical Vision, Ltd. — Product Code GCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1998
Date Received
May 21, 1998
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