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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 K885308
Device Name ELECTRONIC DIGITAL THERMOMETER
Applicant
Ewig Industries Co. , Ltd.
13/F.,Houtex Ind'L Bldg
16 Hung To Rd.,Kwun Tong,
Kowloon, Hong Kong,  HK
Applicant Contact JACKSON CHU
Correspondent
Ewig Industries Co. , Ltd.
13/F.,Houtex Ind'L Bldg
16 Hung To Rd.,Kwun Tong,
Kowloon, Hong Kong,  HK
Correspondent Contact JACKSON CHU
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/27/1988
Decision Date 03/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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