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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 K070231
Device Name ORION
Applicant
NIDEK TECHNOLOGIES SRL
VIA DELL ARTIGIANATO, 6/A
ALBIGNASEGO (PADOVA),  IT 35020
Applicant Contact ALDO COCCHIGLIA
Correspondent
NIDEK TECHNOLOGIES SRL
VIA DELL ARTIGIANATO, 6/A
ALBIGNASEGO (PADOVA),  IT 35020
Correspondent Contact ALDO COCCHIGLIA
Regulation Number886.1120
Classification Product Code
HKI  
Date Received01/24/2007
Decision Date 04/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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