FDA 510(k) Application Details - K063617

Device Classification Name Media, Corneal Storage

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510(K) Number K063617
Device Name Media, Corneal Storage
Applicant AL.CHI.MI.A
377 ROUTE 17 S
HASBROUCK HEIGHTS, NJ 07604 US
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Contact GEORGE MYERS
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Regulation Number 000.0000

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Classification Product Code LYX
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Date Received 12/05/2006
Decision Date 02/08/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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