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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 K030658
Device Name STANDARD THERMOMETER
Applicant
GLOBAL TREASURE INDUSTRIES LTD.
163 CABOT ST.
BEVERLY,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
GLOBAL TREASURE INDUSTRIES LTD.
163 CABOT ST.
BEVERLY,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/03/2003
Decision Date 03/25/2003
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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