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FDA 510(k) Application Details - K161794
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K161794
Device Name
Unit, Phacofragmentation
Applicant
Alcon Research, Ltd.
6201 SOUTH FREEWAY DR.
FORT WORTH, TX 76134-2099 US
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Contact
Paul Swift
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
06/30/2016
Decision Date
04/14/2017
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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