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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 K880759
Device Name MODIFIED DIGITAL CLINICAL THERMOMETER
Applicant
Epson America, Inc.
3415 Kashiwa St.
Torrance,  CA  90505
Applicant Contact JAN SOUZA
Correspondent
Epson America, Inc.
3415 Kashiwa St.
Torrance,  CA  90505
Correspondent Contact JAN SOUZA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/25/1988
Decision Date 06/24/1988
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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