FDA 510(k) Application Details - K110606

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K110606
Device Name Needle, Hypodermic, Single Lumen
Applicant M.V. S.R.L.
VIA MARZIA 9
ABANO TERME PADOVA 35031 IT
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Contact ENRICO BISSON
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 03/03/2011
Decision Date 09/29/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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