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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 K093210
Device Name AQUALASE CAPSULE WASH TIP
Applicant
Alcon Manufacturing, Ltd.
15800 Alton Pkwy.
Irvine,  CA  92618 -3818
Applicant Contact MARTIN A KAUFMAN
Correspondent
Alcon Manufacturing, Ltd.
15800 Alton Pkwy.
Irvine,  CA  92618 -3818
Correspondent Contact MARTIN A KAUFMAN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/13/2009
Decision Date 03/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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