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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 K853551
Device Name YSI MODEL 790 TELE-THERMOMETER
Applicant
Yellow Springs Instrument Co., Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
Applicant Contact HENRY SOSTMAN
Correspondent
Yellow Springs Instrument Co., Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
Correspondent Contact HENRY SOSTMAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/26/1985
Decision Date 09/19/1985
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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