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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 K130361
Device Name THERMOFINDER; THERMOCARE
Applicant
Hubdic Co., Ltd.
504 Bluegrass Dr.
Canonsburg,  PA  15317
Applicant Contact MATT HANSEN
Correspondent
Pharmalink Technical Group, LLC
20 F St., NW
Washington,  DC  20001
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/13/2013
Decision Date 04/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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