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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Specular
510(k) Number K130565
Device Name SPECULAR MICROSCOPE CEM-530
Applicant
Nidek Co., Ltd.
300 Brickstone Square
Andover,  MA  01810
Applicant Contact Aron Shapiro
Correspondent
Nidek Co., Ltd.
300 Brickstone Square
Andover,  MA  01810
Correspondent Contact Aron Shapiro
Regulation Number886.1850
Classification Product Code
NQE  
Date Received03/04/2013
Decision Date 11/27/2013
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
Recalls CDRH Recalls
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