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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 K843040
Device Name COPAL DIGITAL THERMOMETER UF-10
Applicant
Takeda Medical, Inc.
17945Skypark Cir.
Irvine,  CA  92714
Applicant Contact HUGH NAMEKAWA
Correspondent
Takeda Medical, Inc.
17945Skypark Cir.
Irvine,  CA  92714
Correspondent Contact HUGH NAMEKAWA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/02/1984
Decision Date 01/03/1985
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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