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FDA 510(k) Application Details - K131519
Device Classification Name
Warmer, Thermal, Infusion Fluid
More FDA Info for this Device
510(K) Number
K131519
Device Name
Warmer, Thermal, Infusion Fluid
Applicant
BELMONT INSTRUMENT CORP.
780 BOSTON RD.
BILLERICA, MA 01821 US
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Contact
SABRINA BELLADUE
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Regulation Number
000.0000
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Classification Product Code
LGZ
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More FDA Info for this Product Code
Date Received
05/28/2013
Decision Date
11/06/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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