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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 K193213
Device Name Vicks VNT200 No Touch Forehead Thermometer
Applicant
Kaz USA, Inc., A Helen of Troy Company
400 Donald Lynch Blvd., Suite 300
Marlborough,  MA  01752
Applicant Contact Matt J. Baun
Correspondent
Kaz USA, Inc., A Helen of Troy Company
400 Donald Lynch Blvd., Suite 300
Marlborough,  MA  01752
Correspondent Contact Matt J. Baun
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/21/2019
Decision Date 04/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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