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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drum, eye knife test
510(k) Number K926412
Device Name MICRON-SCOPE II
Applicant
CHIRON VISION CORP.
9342 JERONIMO RD.
IRVINE,  CA  92618 -1903
Applicant Contact CAROL L PATTERSON
Correspondent
CHIRON VISION CORP.
9342 JERONIMO RD.
IRVINE,  CA  92618 -1903
Correspondent Contact CAROL L PATTERSON
Regulation Number886.4230
Classification Product Code
HMS  
Subsequent Product Code
KEJ  
Date Received12/21/1992
Decision Date 07/19/1994
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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