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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 K936302
Device Name NIDEK MODEL VT-4000, MODIFICATION
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 Received12/29/1993
Decision Date 07/15/1994
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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