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FDA 510(k) Application Details - K992258
Device Classification Name
More FDA Info for this Device
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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More FDA Info for this Product Code
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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