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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K885196
Device Name LASER INDIRECT OPHTHALMOSCOPE (LIO)
Applicant
COHERENT MEDICAL GROUP
3270 W. BAYSHORE RD.
P.O. BOX 10122
PALO ALTO,  CA  94303
Applicant Contact ALAN VOSS
Correspondent
COHERENT MEDICAL GROUP
3270 W. BAYSHORE RD.
P.O. BOX 10122
PALO ALTO,  CA  94303
Correspondent Contact ALAN VOSS
Regulation Number886.4150
Classification Product Code
HQE  
Date Received12/16/1988
Decision Date 01/11/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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