FDA 510(k) Application Details - K032778

Device Classification Name Warmer, Thermal, Infusion Fluid

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510(K) Number K032778
Device Name Warmer, Thermal, Infusion Fluid
Applicant BELMONT INSTRUMENT CORP.
780 BOSTON RD.
BILLERICA, MA 01821 US
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Contact URAIWAN P LABADINI
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Regulation Number 000.0000

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Classification Product Code LGZ
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Date Received 09/08/2003
Decision Date 09/22/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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