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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 K132323
Device Name RS-3000 ADVANCE
Applicant
Nidek Co., Ltd.
1667 Ridgewood Rd.
Wadsworth,  OH  44281
Applicant Contact LENA SATTLER
Correspondent
Nidek Co., Ltd.
1667 Ridgewood Rd.
Wadsworth,  OH  44281
Correspondent Contact LENA SATTLER
Regulation Number886.1570
Classification Product Code
OBO  
Date Received07/25/2013
Decision Date 02/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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