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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K951079
Device Name NIDEK MODEL GYC-1500 AND GYC-2000
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 Number886.4390
Classification Product Code
HQF  
Date Received03/09/1995
Decision Date 09/14/1995
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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