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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 K950881
Device Name PHACO TIP
Applicant
American Optical Corp.
19 Hammond
Suite 505
Irvine,  CA  92718
Applicant Contact GLENN A DUNKI-JACOBS
Correspondent
American Optical Corp.
19 Hammond
Suite 505
Irvine,  CA  92718
Correspondent Contact GLENN A DUNKI-JACOBS
Regulation Number886.4670
Classification Product Code
HQC  
Date Received02/27/1995
Decision Date 09/06/1995
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
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