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FDA 510(k) Application Details - K031390
Device Classification Name
Warmer, Thermal, Infusion Fluid
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510(K) Number
K031390
Device Name
Warmer, Thermal, Infusion Fluid
Applicant
MINIMED, INC.
18000 DEVONSHIRE ST.
NORTHRIDGE, CA 91325 US
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Contact
MIRIELLE MENGOTTO
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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
05/02/2003
Decision Date
07/23/2003
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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