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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image, Illumination, Fiberoptic, For Endoscope
510(k) Number K983714
Device Name SOLARTEC SOURCE 270, MODEL # 90123
Applicant
COGENT LIGHT TECHNOLOGIES, INC.
26145 TECHNOLOGY DR.
SANTA CLARITA,  CA  91355 -1137
Applicant Contact DON KNAEPPLE
Correspondent
COGENT LIGHT TECHNOLOGIES, INC.
26145 TECHNOLOGY DR.
SANTA CLARITA,  CA  91355 -1137
Correspondent Contact DON KNAEPPLE
Regulation Number876.1500
Classification Product Code
FFS  
Date Received10/21/1998
Decision Date 12/23/1998
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
Predetermined Change
Control Plan Authorized		 No
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