510(k) K971057

COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM by Cogent Light Technologies, Inc. — Product Code GCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1997
Date Received
March 24, 1997
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