FDA 510(k) Application Details - K073591

Device Classification Name Folders And Injectors, Intraocular Lens (Iol)

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510(K) Number K073591
Device Name Folders And Injectors, Intraocular Lens (Iol)
Applicant STAAR SURGICAL CO.
1911 WALKER AVE.
MONROVIA, CA 91016 US
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Contact DIANA SMITH
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Regulation Number 886.4300

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Classification Product Code MSS
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Date Received 12/20/2007
Decision Date 03/13/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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