FDA 510(k) Application Details - K101782

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

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510(K) Number K101782
Device Name Folders And Injectors, Intraocular Lens (Iol)
Applicant STAAR JAPAN
1911 WALKER AVENUE
MONROVIA, CA 91016 US
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Contact JACK COGGAN
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Regulation Number 886.4300

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Classification Product Code MSS
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Date Received 06/25/2010
Decision Date 12/22/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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