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FDA 510(k) Application Details - K212039
Device Classification Name
Folders And Injectors, Intraocular Lens (Iol)
More FDA Info for this Device
510(K) Number
K212039
Device Name
Folders And Injectors, Intraocular Lens (Iol)
Applicant
ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134 US
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Contact
Jwalitha Shankardas
Other 510(k) Applications for this Contact
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
06/30/2021
Decision Date
08/23/2021
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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