510(k) K983714

SOLARTEC SOURCE 270, MODEL # 90123 by Cogent Light Technologies, Inc. — Product Code FFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1998
Date Received
October 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image, Illumination, Fiberoptic, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type