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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 K843276
Device Name IOCARE CONVERTER KIT
Applicant
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact TICKNOR
Correspondent
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact TICKNOR
Regulation Number886.4670
Classification Product Code
HQC  
Date Received08/20/1984
Decision Date 05/09/1985
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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