FDA 510(k) Application Details - K090508

Device Classification Name Warmer, Blood, Non-Electromagnetic Radiation

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510(K) Number K090508
Device Name Warmer, Blood, Non-Electromagnetic Radiation
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 864.9205

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Classification Product Code BSB
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Date Received 02/26/2009
Decision Date 03/26/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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