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FDA 510(k) Application Details - K060366
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K060366
Device Name
Unit, Phacofragmentation
Applicant
ADVANCED MEDICAL OPTICS, INC.
1700 EAST ST. ANDREW PL.
MAIL STOP: SA-2J
SANTA ANA, CA 92799 US
Other 510(k) Applications for this Company
Contact
TONI ELLIOTT
Other 510(k) Applications for this Contact
Regulation Number
886.4670
More FDA Info for this Regulation Number
Classification Product Code
HQC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/13/2006
Decision Date
04/07/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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