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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 K070342
Device Name CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413
Applicant
American I.V. Products, Inc.
7485 Shipley Ave.
Harmans,  MD  21077
Applicant Contact JOHN TAYLOR
Correspondent
American I.V. Products, Inc.
7485 Shipley Ave.
Harmans,  MD  21077
Correspondent Contact JOHN TAYLOR
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/06/2007
Decision Date 03/19/2007
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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