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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 K843966
Device Name ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS
Applicant
AMERICAN MEDICAL OPTICS
1402 EAST ALTON AVE.
IRVINE,  CA  92714
Applicant Contact GEORGIA CONRAD
Correspondent
AMERICAN MEDICAL OPTICS
1402 EAST ALTON AVE.
IRVINE,  CA  92714
Correspondent Contact GEORGIA CONRAD
Regulation Number886.4690
Classification Product Code
HQB  
Date Received10/11/1984
Decision Date 11/08/1984
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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