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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K113451
Device Name NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
Applicant
NIDEK TECHNOLOGIES SRL
VIA DELL ARTIGIANATO, 6/A
ALBIGNASEGO (PADOVA),  IT 35020
Applicant Contact ENRICO BISSON
Correspondent
NIDEK TECHNOLOGIES SRL
VIA DELL ARTIGIANATO, 6/A
ALBIGNASEGO (PADOVA),  IT 35020
Correspondent Contact ENRICO BISSON
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Codes
NFF   NFG  
Date Received11/21/2011
Decision Date 05/08/2012
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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