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FDA 510(k) Application Details - K073010
Device Classification Name
Folders And Injectors, Intraocular Lens (Iol)
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510(K) Number
K073010
Device Name
Folders And Injectors, Intraocular Lens (Iol)
Applicant
ASICO LLC
26 PLAZA DR.
WESTMONT, IL 60559 US
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Contact
RAVI NALLAKRISHNAN
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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
10/25/2007
Decision Date
11/07/2007
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
Y
Expedited Review
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