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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K913929
Device Name DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
Applicant
Ophthalmic Imaging Systems
221 Lathrop Way, Suite I
Sacramento,  CA  95815
Applicant Contact STEVEN R VERDOONER
Correspondent
Ophthalmic Imaging Systems
221 Lathrop Way, Suite I
Sacramento,  CA  95815
Correspondent Contact STEVEN R VERDOONER
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
NFJ  
Date Received09/03/1991
Decision Date 11/27/1991
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
Recalls CDRH Recalls
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