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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K133132
Device Name OPTICAL BIOMETER AL-SCAN
Applicant
Nidek Co., Ltd.
755 N Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Applicant Contact DARLENE CROCKETT-BILLIG
Correspondent
Nidek Co., Ltd.
755 N Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Correspondent Contact DARLENE CROCKETT-BILLIG
Regulation Number886.1850
Classification Product Code
HJO  
Subsequent Product Code
IYO  
Date Received09/30/2013
Decision Date 06/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT01729962
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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