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FDA 510(k) Application Details - K993950
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K993950
Device Name
Thermometer, Electronic, Clinical
Applicant
NIEN MADE ELECTRNICS CORP.
100 MAIN ST.
SUITE 120
CONCORD, MA 01742 US
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Contact
JAMES M DELANEY
Other 510(k) Applications for this Contact
Regulation Number
880.2910
More FDA Info for this Regulation Number
Classification Product Code
FLL
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More FDA Info for this Product Code
Date Received
11/22/1999
Decision Date
08/23/2000
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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