FDA 510(k) Application Details - K973748

Device Classification Name Warmer, Thermal, Infusion Fluid

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510(K) Number K973748
Device Name Warmer, Thermal, Infusion Fluid
Applicant SMITH
P.O. BOX 4341
CROFTON, MD 21114 US
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Contact DURWARD FARIES, JR.
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Regulation Number 000.0000

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Classification Product Code LGZ
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Date Received 10/01/1997
Decision Date 03/10/1998
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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