FDA 510(k) Application Details - K092432

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K092432
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant JAWON MEDICAL CO., LTD.
#1208-12, Sinsang-Li, Jinryang-Myun
Kyungsan-city, Kyungsan-Bukdo 712-830 KR
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Contact H L JUNG
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 08/07/2009
Decision Date 10/09/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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