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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 K101747
Device Name BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE
Applicant
KAZ USA, INC (A SUBSIDIARYOF KAZ INC)
250 TURNPIKE ROAD
SOUTHBOROUGH,  MA  01772
Applicant Contact RAJ KASBEKAR
Correspondent
KAZ USA, INC (A SUBSIDIARYOF KAZ INC)
250 TURNPIKE ROAD
SOUTHBOROUGH,  MA  01772
Correspondent Contact RAJ KASBEKAR
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/22/2010
Decision Date 08/04/2010
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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