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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 K912354
Device Name OLYMOUS XLS XENON LIGHT SOURCE
Applicant
PERKIN ELMER OPTOELECTRONICS
399 W.JAVA DR.
SUUNYVALE,  CA  94089
Applicant Contact SCHUDA PH.D.
Correspondent
PERKIN ELMER OPTOELECTRONICS
399 W.JAVA DR.
SUUNYVALE,  CA  94089
Correspondent Contact SCHUDA PH.D.
Regulation Number876.1500
Classification Product Code
GCT  
Date Received05/28/1991
Decision Date 08/16/1991
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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