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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K880929
Device Name NIDEK CV-4000
Applicant
Nidek, Inc.
2460 Embarcadero Way
P.O.Box 50488
Palo Alto,  CA  94303
Applicant Contact CARL R JORDAN
Correspondent
Nidek, Inc.
2460 Embarcadero Way
P.O.Box 50488
Palo Alto,  CA  94303
Correspondent Contact CARL R JORDAN
Regulation Number886.4150
Classification Product Code
HQE  
Date Received03/04/1988
Decision Date 05/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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