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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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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