FDA 510(k) Application Details - K120026

Device Classification Name Warmer, Thermal, Infusion Fluid

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510(K) Number K120026
Device Name Warmer, Thermal, Infusion Fluid
Applicant RAND S.R.L.
VIA STATALE 12,62
MEDOLLA, (MO) 41036 IT
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Contact SIMONE CERETTI
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Regulation Number 000.0000

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Classification Product Code LGZ
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Date Received 01/03/2012
Decision Date 05/08/2012
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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