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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photocoagulator And Accessories
510(k) Number K844356
Device Name SYSTEM 930 ARGON PHOTOCOAGULATOR
Applicant
COHERENT MEDICAL GROUP
3270 W. BAYSHORE RD.
P.O. BOX 10122
PALO ALTO,  CA  94303
Applicant Contact THEODORE A BOUTACOF
Correspondent
COHERENT MEDICAL GROUP
3270 W. BAYSHORE RD.
P.O. BOX 10122
PALO ALTO,  CA  94303
Correspondent Contact THEODORE A BOUTACOF
Regulation Number886.4690
Classification Product Code
HQB  
Date Received11/09/1984
Decision Date 05/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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