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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tonometer, ac-powered
510(k) Number K913189
Device Name NIDEK MODEL NT-1000
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 Number886.1930
Classification Product Code
HKX  
Date Received07/18/1991
Decision Date 10/15/1991
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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