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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 K972808
Device Name HANSATOME MICROKERATOME
Applicant
CHIRON VISION CORP.
9342 JERONIMO RD.
IRVINE,  CA  92618 -1903
Applicant Contact JUDY F GORDON
Correspondent
CHIRON VISION CORP.
9342 JERONIMO RD.
IRVINE,  CA  92618 -1903
Correspondent Contact JUDY F GORDON
Regulation Number886.4370
Classification Product Code
HNO  
Date Received07/28/1997
Decision Date 10/24/1997
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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