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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 K050648
Device Name SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
Applicant
Advanced Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana,  CA  92705
Applicant Contact PAM SCHAUB
Correspondent
Advanced Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana,  CA  92705
Correspondent Contact PAM SCHAUB
Regulation Number886.4670
Classification Product Code
HQC  
Date Received03/14/2005
Decision Date 04/05/2005
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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