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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 K844209
Device Name ARGON/KRYPTON LASER SYSTEM 8500
Applicant
COOPER LASERSONICS, INC.
3420 Central Expressway
Santa Clara,  CA  95051
Applicant Contact CHARLES L ROSE
Correspondent
COOPER LASERSONICS, INC.
3420 Central Expressway
Santa Clara,  CA  95051
Correspondent Contact CHARLES L ROSE
Regulation Number886.4690
Classification Product Code
HQB  
Date Received10/31/1984
Decision Date 02/06/1985
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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