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FDA 510(k) Application Details - K100563
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K100563
Device Name
Thermometer, Electronic, Clinical
Applicant
GEON CORPORATION
2904 N. BOLDT DRIVE
FLAGSTAFF, AZ 86001 US
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Contact
JENNIFER REICH
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
03/01/2010
Decision Date
06/02/2010
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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