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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 K013337
Device Name PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
Applicant
SURGIN INC
14762 BENTLEY CIRCLE
TUSTIN,  CA  92680
Applicant Contact DON HAAR
Correspondent
SURGIN INC
14762 BENTLEY CIRCLE
TUSTIN,  CA  92680
Correspondent Contact DON HAAR
Regulation Number886.4370
Classification Product Code
HNO  
Date Received10/09/2001
Decision Date 12/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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