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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Management, Ophthalmic
510(k) Number K110006
Device Name OIS SYMPHONY IMAGE MANAGMENT SYSTEM
Applicant
OPHTHALMIC IMAGING SYSTEMS
221 LATHROP WAY, SUITE I
SACRAMENTO,  CA  95815
Applicant Contact ANDREA AMBROSE
Correspondent
OPHTHALMIC IMAGING SYSTEMS
221 LATHROP WAY, SUITE I
SACRAMENTO,  CA  95815
Correspondent Contact ANDREA AMBROSE
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received01/03/2011
Decision Date 05/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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