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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, Fiberoptic, Routine
510(k) Number K903790
Device Name ENDOSCOPIC LIGHT SOURCE 250 ENDO
Applicant
Orlux Engineering and Instrumentation
18 Strathearn Ave.
Unit 6c
Brampton, Ontario,  CA L6T 4X9
Applicant Contact MICHAEL TACHICH
Correspondent
Orlux Engineering and Instrumentation
18 Strathearn Ave.
Unit 6c
Brampton, Ontario,  CA L6T 4X9
Correspondent Contact MICHAEL TACHICH
Regulation Number876.1500
Classification Product Code
FCW  
Date Received08/20/1990
Decision Date 12/07/1990
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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