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FDA 510(k) Application Details - K962497
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K962497
Device Name
Thermometer, Electronic, Clinical
Applicant
FAICHNEY MEDICAL CO.
17159 SURREY VIEW DR.
CHESTERFIELD, MO 63005 US
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Contact
M. JAMES DAVIS
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
06/26/1996
Decision Date
10/08/1996
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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