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FDA 510(k) Application Details - K003768
Device Classification Name
Folders And Injectors, Intraocular Lens (Iol)
More FDA Info for this Device
510(K) Number
K003768
Device Name
Folders And Injectors, Intraocular Lens (Iol)
Applicant
ALCON RESEARCH, LTD.
6201 SOUTH FREEWAY
FORT WORTH, TX 76134-2099 US
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Contact
SHERRI J LAKOTA
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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
12/06/2000
Decision Date
01/05/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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