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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 K861063
Device Name NIDEK KM-800 AUTO KERATOMETER
Applicant
NIDEK, INC.
2460 EMBARCADERO WAY
P.O.BOX 50488
PALO ALTO,  CA  94303
Applicant Contact JOHN BRATKOWSKY
Correspondent
NIDEK, INC.
2460 EMBARCADERO WAY
P.O.BOX 50488
PALO ALTO,  CA  94303
Correspondent Contact JOHN BRATKOWSKY
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received03/20/1986
Decision Date 04/04/1986
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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