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FDA 510(k) Application Details - K031478
Device Classification Name
Warmer, Blood, Non-Electromagnetic Radiation
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510(K) Number
K031478
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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More FDA Info for this Product Code
Date Received
05/12/2003
Decision Date
07/02/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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