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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 K092557
Device Name DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES
Applicant
Harvard Medical Devices , Ltd.
39 Chatham Rd. S.
Tsimshatsui, Kowloon,  HK
Applicant Contact MARTIN MA
Correspondent
Harvard Medical Devices , Ltd.
39 Chatham Rd. S.
Tsimshatsui, Kowloon,  HK
Correspondent Contact MARTIN MA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/20/2009
Decision Date 12/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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