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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tomography, optical coherence
510(k) Number K121622
Device Name NIDEK RS-3000
Original Applicant
NIDEK CO., LTD.
1667 ridgewood rd
wadsworth,  OH  44281
Original Contact lena sattler
Regulation Number886.1570
Classification Product Code
OBO  
Date Received06/01/2012
Decision Date 03/14/2013
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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