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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, endoscope, xenon arc
510(k) Number K933405
Device Name COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE
Applicant
COGENT LIGHT TECHNOLOGIES, INC.
650 SOUTH SAN VINCENT BLVD.
LOS ANGELES,  CA  90048 -4620
Applicant Contact ROBERT J BARD
Correspondent
COGENT LIGHT TECHNOLOGIES, INC.
650 SOUTH SAN VINCENT BLVD.
LOS ANGELES,  CA  90048 -4620
Correspondent Contact ROBERT J BARD
Regulation Number876.1500
Classification Product Code
GCT  
Date Received07/12/1993
Decision Date 02/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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