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FDA 510(k) Application Details - K082845
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K082845
Device Name
Unit, Phacofragmentation
Applicant
ALCON RESEARCH, LTD.
6201 SOUTH FREEWAY
FORT WORTH, TX 76134-2099 US
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Contact
MICHAEL BUENGER
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
09/26/2008
Decision Date
02/12/2009
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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