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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K951829
Device Name COLD LIGHT SOURCE LOS 150
Applicant
Laser-Optik-Systeme GmbH & Co. KG
Am Sagewerk 11
Mainz,  DE 55124
Correspondent
Laser-Optik-Systeme GmbH & Co. KG
Am Sagewerk 11
Mainz,  DE 55124
Regulation Number874.4350
Classification Product Code
EQH  
Date Received04/20/1995
Decision Date 07/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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