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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 K152975
Device Name VDT985US Vicks SmartTemp Thermometer
Applicant
Kaz USA, Inc., A Helen of Troy Company
250 Turnpike Rd.
Southborough,  MA  01772
Applicant Contact Raj Kasbekar
Correspondent
Kaz USA, Inc., A Helen of Troy Company
250 Turnpike Rd.
Southborough,  MA  01772
Correspondent Contact Raj Kasbekar
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/08/2015
Decision Date 03/23/2016
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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