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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, fiberoptic
510(k) Number K903800
Device Name FIBER OPTIC LIGHT CABLE
Applicant
ORLUX ENGINEERING AND INSTRUMENTATION
18 STRATHEARN AVENUE
UNIT 6C
BRAMPTON, ONTARIO,  CA L6T 4X9
Applicant Contact MICHAEL TACHICH
Correspondent
ORLUX ENGINEERING AND INSTRUMENTATION
18 STRATHEARN AVENUE
UNIT 6C
BRAMPTON, ONTARIO,  CA L6T 4X9
Correspondent Contact MICHAEL TACHICH
Regulation Number878.4580
Classification Product Code
FST  
Date Received08/20/1990
Decision Date 08/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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