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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Ocular
510(k) Number K925606
Device Name OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS
Applicant
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact CAROL L PATTERSON
Correspondent
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact CAROL L PATTERSON
Regulation Number886.4570
Classification Product Code
HMR  
Date Received11/05/1992
Decision Date 08/29/1994
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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