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FDA 510(k) Application Details - K160236
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K160236
Device Name
Unit, Phacofragmentation
Applicant
Abbott Medical Optics Inc.
1700 East Saint Andrew Place
Santa Ana, CA 92705 US
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Contact
Priya Viswanathan
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
02/01/2016
Decision Date
04/27/2016
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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