FDA 510(k) Application Details - K113451

Device Classification Name Camera, Ophthalmic, Ac-Powered

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510(K) Number K113451
Device Name Camera, Ophthalmic, Ac-Powered
Applicant NIDEK TECHNOLOGIES SRL
VIA DELL ARTIGIANATO, 6/A
ALBIGNASEGO (PADOVA) 35020 IT
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Contact ENRICO BISSON
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Regulation Number 886.1120

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Classification Product Code HKI
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Date Received 11/21/2011
Decision Date 05/08/2012
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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