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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 K951462
Device Name AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM
Applicant
Allergan Medical Optics
9701 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact JEANNE ERICKSON
Correspondent
Allergan Medical Optics
9701 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact JEANNE ERICKSON
Regulation Number886.4670
Classification Product Code
HQC  
Date Received03/30/1995
Decision Date 06/15/1995
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
Recalls CDRH Recalls
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