FDA 510(k) Application Details - K181242

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K181242
Device Name Thermometer, Electronic, Clinical
Applicant Kaz USA, Inc., A Helen of Troy Company
400 Donald Lynch Boulevard, Suite 300
Marlborough, MA 01752 US
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Contact Matt J. Baun
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 05/10/2018
Decision Date 07/23/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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