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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name refractometer, ophthalmic
510(k) Number K902500
Device Name AR-1600G AUTO-REFRACTOMETER
Applicant
NIDEK, INC.
2460 EMBARCADERO WAY
P.O.BOX 50488
PALO ALTO,  CA  94303
Applicant Contact KEN KATO
Correspondent
NIDEK, INC.
2460 EMBARCADERO WAY
P.O.BOX 50488
PALO ALTO,  CA  94303
Correspondent Contact KEN KATO
Regulation Number886.1760
Classification Product Code
HKO  
Date Received06/05/1990
Decision Date 07/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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