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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 K134043
Device Name NO TOUCH+FOREHEAD NTF 3000 THERMOMETER
Applicant
Kaz USA, Inc (A Subsidiaryof Kaz Inc)
250 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact RAJ KASBEKAR
Correspondent
Kaz USA, Inc (A Subsidiaryof Kaz Inc)
250 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact RAJ KASBEKAR
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/31/2013
Decision Date 05/21/2014
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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