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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K912918
Device Name IRIS OCULIGHT DIODE LASER ADDING SLIT LAMP ADAPTER
Applicant
Iriderm Div.
340 Pioneer Way
Mountain View,  CA  94041
Applicant Contact THEODORE BOUTACOFF
Correspondent
Iriderm Div.
340 Pioneer Way
Mountain View,  CA  94041
Correspondent Contact THEODORE BOUTACOFF
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/03/1991
Decision Date 08/23/1991
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
Predetermined Change
Control Plan Authorized		 No
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