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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photocoagulator And Accessories
510(k) Number K111493
Device Name NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
Applicant
Nidek Co., Ltd.
755 N Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Applicant Contact MICHAEL J BILLIG
Correspondent
Nidek Co., Ltd.
755 N Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Correspondent Contact MICHAEL J BILLIG
Regulation Number886.4690
Classification Product Code
HQB  
Subsequent Product Code
HQF  
Date Received05/31/2011
Decision Date 07/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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