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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 K892145
Device Name FIBER OPTIC LIGHT TRANSMISSION CABLE
Applicant
Opto Vision, Inc.
4849 N. Kenneth Ave.
Chicago,  IL  60630
Applicant Contact HELMUT KREBS
Correspondent
Opto Vision, Inc.
4849 N. Kenneth Ave.
Chicago,  IL  60630
Correspondent Contact HELMUT KREBS
Regulation Number876.1500
Classification Product Code
FFS  
Date Received03/30/1989
Decision Date 09/29/1989
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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