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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K944993
Device Name IOLAB.SITE CD PHACOEMULSIFICATION MODULE
Applicant
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact DONNA A CRAWFORD
Correspondent
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact DONNA A CRAWFORD
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/12/1994
Decision Date 10/12/1995
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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