SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK

Unit, Phacofragmentation

ADVANCED MEDICAL OPTICS, INC.

The following data is part of a premarket notification filed by Advanced Medical Optics, Inc. with the FDA for Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack.

Pre-market Notification Details

Device IDK050648
510k NumberK050648
Device Name:SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
ClassificationUnit, Phacofragmentation
Applicant ADVANCED MEDICAL OPTICS, INC. 1700 EAST ST. ANDREW PL. Santa Ana,  CA  92705
ContactPam Schaub
CorrespondentPam Schaub
ADVANCED MEDICAL OPTICS, INC. 1700 EAST ST. ANDREW PL. Santa Ana,  CA  92705
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-14
Decision Date2005-04-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D2481550190 K050648 000
D2481550180 K050648 000

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