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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 K061007
Device Name GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS
Applicant
Good Medy Enterprise , Ltd.
1 F., # 72, Alley 33
Lane 514, Jongieng Rd.
Shingjuang City, Taipei,  TW 24255
Applicant Contact JEN KE-MIN
Correspondent
Good Medy Enterprise , Ltd.
1 F., # 72, Alley 33
Lane 514, Jongieng Rd.
Shingjuang City, Taipei,  TW 24255
Correspondent Contact JEN KE-MIN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/11/2006
Decision Date 06/14/2006
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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