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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 K182652
Device Name COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10
Applicant
Kangfu Medical Equipment Factory
# 380 Ningkang E. Rd.
Yueqing City,  CN 325600
Applicant Contact Zelong Cao
Correspondent
Kangfu Medical Equipment Factory
# 380 Ningkang E. Rd.
Yueqing City,  CN 325600
Correspondent Contact Zelong Cao
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/24/2018
Decision Date 11/20/2018
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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