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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name keratome, ac-powered
510(k) Number K990900
Device Name MICROKERATOME, MODEL MK-2000
Applicant
NIDEK, INC.
47651 WESTINGHOUSE DR.
FREMONT,  CA  94539
Applicant Contact JERRY TSUTSUMI
Correspondent
NIDEK, INC.
47651 WESTINGHOUSE DR.
FREMONT,  CA  94539
Correspondent Contact JERRY TSUTSUMI
Regulation Number886.4370
Classification Product Code
HNO  
Date Received03/18/1999
Decision Date 09/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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