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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name keratoscope, ac-powered
510(k) Number K003299
Device Name OPD-SCAN, MODELS ARK-10000 AND ARK-9000
Applicant
NIDEK CO., LTD.
21911 ERIE LN.
LAKE FOREST,  CA  92630
Applicant Contact CAROL PATTERSON
Correspondent
NIDEK CO., LTD.
21911 ERIE LN.
LAKE FOREST,  CA  92630
Correspondent Contact CAROL PATTERSON
Regulation Number886.1350
Classification Product Code
HLQ  
Subsequent Product Code
HKO  
Date Received10/20/2000
Decision Date 03/09/2001
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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