FDA 510(k) Application Details - K992258

Device Classification Name

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510(K) Number K992258
Device Name HOT SHOT FLUID WARMER IV FLUIDS
Applicant INFRA-MED TECHNOLOGIES, INC.
3535 FIREWHEEL DRIVE, SUITE A
FLOWER MOUND, TX 75028-2628 US
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Contact BERTRAM J HUDSON
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Regulation Number

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Classification Product Code LDQ
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Date Received 07/06/1999
Decision Date 01/12/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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