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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 K924353
Device Name NIDEK MODEL VST-4000
Applicant
NIDEK, INC.
47651 WESTINGHOUSE DR.
FREMONT,  CA  94539
Applicant Contact KEN KATO
Correspondent
NIDEK, INC.
47651 WESTINGHOUSE DR.
FREMONT,  CA  94539
Correspondent Contact KEN KATO
Regulation Number886.4150
Classification Product Code
HQE  
Date Received08/28/1992
Decision Date 03/29/1993
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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