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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K163516
Device Name Braun No Touch + Forehead NTF3000 Thermometer
Applicant
Kaz USA, Inc., A Helen of Troy Company
400 Donald Lynch Blvd., Suite 300
Marlborough,  MA  01752
Applicant Contact Rajesh Kasbekar
Correspondent
Kaz USA, Inc., A Helen of Troy Company
400 Donald Lynch Blvd., Suite 300
Marlborough,  MA  01752
Correspondent Contact Rajesh Kasbekar
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/15/2016
Decision Date 04/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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