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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 K834340
Device Name IOCARE IRRIGATION & ASPIRATION PACK
Applicant
CHIRON VISION CORP.
9342 JERONIMO RD.
IRVINE,  CA  92618 -1903
Correspondent
CHIRON VISION CORP.
9342 JERONIMO RD.
IRVINE,  CA  92618 -1903
Regulation Number886.4670
Classification Product Code
HQC  
Date Received12/12/1983
Decision Date 04/05/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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