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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.
Valencia,  CA  91355
Applicant Contact DON KNAEPPLE
Correspondent
Cogent Light Technologies, Inc.
26145 Technology Dr.
Valencia,  CA  91355
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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