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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 K102718
Device Name DIGITAL THERMOMETER; DIGITAL THERMOMETER
Applicant
International Regulatory Consultants, LLC (Irc)
16f-2(16a), Sec. 2
Chong De Rd.
Taichung,  CN 406
Applicant Contact JACOB CHANG
Correspondent
International Regulatory Consultants, LLC (Irc)
16f-2(16a), Sec. 2
Chong De Rd.
Taichung,  CN 406
Correspondent Contact JACOB CHANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/21/2010
Decision Date 12/13/2010
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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