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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K894273
Device Name NIDEK MODEL AKC-8000
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 Number886.4390
Classification Product Code
HQF  
Date Received06/22/1989
Decision Date 08/07/1989
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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