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FDA 510(k) Application Details - K152975
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K152975
Device Name
Thermometer, Electronic, Clinical
Applicant
Kaz USA, Inc., a Helen of Troy Company
250 Turnpike Road
Southborough, MA 01772 US
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Contact
Raj Kasbekar
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
10/08/2015
Decision Date
03/23/2016
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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