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FDA 510(k) Application Details - K133486
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K133486
Device Name
Unit, Phacofragmentation
Applicant
BAUSCH & LOMB
3365 TREE CT. INDUSTRIAL BLVD
ST. LOUIS, MO 63122 US
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Contact
TIMOTHY W CAPEHART
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
11/13/2013
Decision Date
03/12/2014
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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