FDA 510(k) Application Details - K024373

Device Classification Name Warmer, Thermal, Infusion Fluid

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510(K) Number K024373
Device Name Warmer, Thermal, Infusion Fluid
Applicant ELLTEC CO., LTD.
SHIRAKAWA NO. 6 BLDG.
2-18-5, NISHIKI, NAKA-KU
NAGOYA 460-0003 JP
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Contact RIEKO SO
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Regulation Number 000.0000

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Classification Product Code LGZ
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Date Received 12/31/2002
Decision Date 01/28/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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