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FDA 510(k) Application Details - K192005
Device Classification Name
Folders And Injectors, Intraocular Lens (Iol)
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510(K) Number
K192005
Device Name
Folders And Injectors, Intraocular Lens (Iol)
Applicant
Bausch & Lomb, Inc
3365 Tree ct. Industrial Blvd.
St. Louis, MO 63122 US
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Contact
Rekha Janarthanan
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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
07/29/2019
Decision Date
10/04/2019
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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