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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 K191978
Device Name Fever Garde
Applicant
Hubdic Co., Ltd.
301, 53 Jeonpa-Ro, Manan-Gu, Anyang-Si, Gyeongg-Do
Anyang-Si,  KR 14084
Applicant Contact Shin Jae-Ho
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/24/2019
Decision Date 12/18/2020
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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