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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
Applicant Contact JUDY F GORDON
Correspondent
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618
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
Predetermined Change
Control Plan Authorized		 No
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