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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K904366
Device Name CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR
Applicant
Douglas James Donaldson Compliance Services
100 Hegenberger Rd.,
Suite 210
Oakland,  CA  94621
Applicant Contact DOUGLAS DONALDSON
Correspondent
Douglas James Donaldson Compliance Services
100 Hegenberger Rd.,
Suite 210
Oakland,  CA  94621
Correspondent Contact DOUGLAS DONALDSON
Regulation Number886.4390
Classification Product Code
HQF  
Date Received09/24/1990
Decision Date 10/19/1990
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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