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FDA 510(k) Application Details - K032434
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K032434
Device Name
Thermometer, Electronic, Clinical
Applicant
COTRONIC MANUFACTURING
JIU WEI, XI XIANG
BAO AN ZONE
SHEN ZHEN CN
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Contact
SHINE WAN
Other 510(k) Applications for this Contact
Regulation Number
880.2910
More FDA Info for this Regulation Number
Classification Product Code
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/06/2003
Decision Date
12/27/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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