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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 K001698
Device Name MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
Applicant
Cogent Light Technologies, Inc.
26145 Technology Dr.
Valencia,  CA  91355
Applicant Contact ED CURRIE
Correspondent
Cogent Light Technologies, Inc.
26145 Technology Dr.
Valencia,  CA  91355
Correspondent Contact ED CURRIE
Regulation Number876.1500
Classification Product Code
FFS  
Subsequent Product Codes
FST   HBI   KOD  
Date Received06/02/2000
Decision Date 07/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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