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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K133358
Device Name NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
Applicant
NIDEK CO., LTD
VIA DELL'ARTIGIANATO, 6/A
ALBIGNASEGO,  IT 35020
Applicant Contact ENRICO BISSON
Correspondent
NIDEK CO., LTD
VIA DELL'ARTIGIANATO, 6/A
ALBIGNASEGO,  IT 35020
Correspondent Contact ENRICO BISSON
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received10/31/2013
Decision Date 08/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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