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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 K120004
Device Name (MULTIPLE) DIGITAL THERMOMETER
Applicant
China Shenyang Med-Land Imp/Exp Corp., Ltd.
19 Sedgemeadow Rd.
Wayland,  MA  01778
Applicant Contact ANN D MCGONIGLE
Correspondent
China Shenyang Med-Land Imp/Exp Corp., Ltd.
19 Sedgemeadow Rd.
Wayland,  MA  01778
Correspondent Contact ANN D MCGONIGLE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/03/2012
Decision Date 08/23/2012
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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