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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light source, endoscope, xenon arc
510(k) Number K971057
Device Name COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM
Applicant
COGENT LIGHT TECHNOLOGIES, INC.
26145 TECHNOLOGY DR.
SANTA CLARITA,  CA  91355 -1137
Applicant Contact RICHARD B DAVIES
Correspondent
COGENT LIGHT TECHNOLOGIES, INC.
26145 TECHNOLOGY DR.
SANTA CLARITA,  CA  91355 -1137
Correspondent Contact RICHARD B DAVIES
Regulation Number876.1500
Classification Product Code
GCT  
Date Received03/24/1997
Decision Date 03/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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