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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 K982689
Device Name WINSTATION RETINAL IMAGER
Applicant
OPHTHALMIC IMAGING SYSTEMS
221 LATHROP WAY, SUITE I
SACRAMENTO,  CA  95815
Applicant Contact BETH A SOPER
Correspondent
OPHTHALMIC IMAGING SYSTEMS
221 LATHROP WAY, SUITE I
SACRAMENTO,  CA  95815
Correspondent Contact BETH A SOPER
Regulation Number886.1120
Classification Product Code
HKI  
Date Received08/03/1998
Decision Date 10/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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