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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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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