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FDA 510(k) Application Details - K103023
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K103023
Device Name
Unit, Phacofragmentation
Applicant
ABBOTT MEDICAL OPTICS INC
1700 E. ST. ANDREW PLACE
SANTA ANA, CA 92705 US
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Contact
Evelyn De La Vega
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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
10/12/2010
Decision Date
06/01/2011
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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