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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 K925631
Device Name PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE
Applicant
CHIRON INTRAOPTICS
9342 JERONIMO RD.
IRVINE,  CA  92718
Applicant Contact CAROL L PATTERSON
Correspondent
CHIRON INTRAOPTICS
9342 JERONIMO RD.
IRVINE,  CA  92718
Correspondent Contact CAROL L PATTERSON
Regulation Number886.4670
Classification Product Code
HQC  
Date Received11/09/1992
Decision Date 07/29/1993
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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