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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 K060366
Device Name THE AMO OPHTHALMIC SURGICAL SYSTEM
Applicant
ADVANCED MEDICAL OPTICS, INC.
1700 EAST ST. ANDREW PL.
MAIL STOP: SA-2J
SANTA ANA,  CA  92799
Applicant Contact TONI ELLIOTT
Correspondent
ADVANCED MEDICAL OPTICS, INC.
1700 EAST ST. ANDREW PL.
MAIL STOP: SA-2J
SANTA ANA,  CA  92799
Correspondent Contact TONI ELLIOTT
Regulation Number886.4670
Classification Product Code
HQC  
Date Received02/13/2006
Decision Date 04/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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