FDA 510(k) Application Details - K110375

Device Classification Name

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510(K) Number K110375
Device Name BLUESHINE'S GOLD SERIES
Applicant BLUESHINE SRL
VIA G. QUERINI 27
MESTRE 30171 IT
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Contact CHIARA RICCI
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Regulation Number

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Classification Product Code PDZ
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Date Received 02/09/2011
Decision Date 02/23/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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