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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 K952028
Device Name COLD LIGHT SOURCE LOS XL-A 100
Applicant
LASER-OPTIK-SYSTEME GMBH & CO. KG
AM SAGEWERK 11
MAINZ,  DE 55124
Applicant Contact MARC STRELOW
Correspondent
LASER-OPTIK-SYSTEME GMBH & CO. KG
AM SAGEWERK 11
MAINZ,  DE 55124
Correspondent Contact MARC STRELOW
Regulation Number876.1500
Classification Product Code
GCT  
Date Received05/01/1995
Decision Date 07/27/1995
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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