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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 K912384
Device Name DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
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 Number886.4150
Classification Product Code
HQE  
Date Received05/28/1991
Decision Date 12/24/1991
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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