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FDA 510(k) Application Details - K050648
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K050648
Device Name
Unit, Phacofragmentation
Applicant
ADVANCED MEDICAL OPTICS, INC.
1700 EAST ST. ANDREW PL.
SANTA ANA, CA 92705 US
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Contact
PAM SCHAUB
Other 510(k) Applications for this Contact
Regulation Number
886.4670
More FDA Info for this Regulation Number
Classification Product Code
HQC
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More FDA Info for this Product Code
Date Received
03/14/2005
Decision Date
04/05/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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