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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aberrometer, Ophthalmic
510(k) Number K050336
Device Name OPD-STATION SOFTWARE
Applicant
Nidek, Inc.
21911 Erie Ln.
Lake Forest,  CA  92630
Applicant Contact CAROL PATTERSON
Correspondent
Nidek, Inc.
21911 Erie Ln.
Lake Forest,  CA  92630
Correspondent Contact CAROL PATTERSON
Regulation Number886.1760
Classification Product Code
NCF  
Subsequent Product Code
MMQ  
Date Received02/10/2005
Decision Date 08/24/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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