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FDA 510(k) Application Details - K133146
Device Classification Name
Folders And Injectors, Intraocular Lens (Iol)
More FDA Info for this Device
510(K) Number
K133146
Device Name
Folders And Injectors, Intraocular Lens (Iol)
Applicant
BAUSCH & LOMB
50 TECHNOLOGY DRIVE
IRVINE, CA 92618 US
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Contact
SHIVANI K CHITALIA
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Regulation Number
886.4300
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Classification Product Code
MSS
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More FDA Info for this Product Code
Date Received
10/17/2013
Decision Date
01/03/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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