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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 K853824
Device Name DIGITAL THERMOMETER
Applicant
Epson America, Inc.
680 Wilshire Pl.
Los Angeles,  CA  90005
Applicant Contact ELON A POLLACK
Correspondent
Epson America, Inc.
680 Wilshire Pl.
Los Angeles,  CA  90005
Correspondent Contact ELON A POLLACK
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/13/1985
Decision Date 11/08/1985
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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