FDA 510(k) Application Details - K092187

Device Classification Name Perimeter, Automatic, Ac-Powered

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510(K) Number K092187
Device Name Perimeter, Automatic, Ac-Powered
Applicant CENTERVUE SPA
VIA TOMMASEO 77
PADOVA 35131 IT
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Contact GIULIANO BARBARO
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Regulation Number 886.1605

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Classification Product Code HPT
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Date Received 07/21/2009
Decision Date 05/27/2010
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 N
Expedited Review



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