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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Strip, Temperature, Forehead, Liquid Crystal
510(k) Number K802897
Device Name ELECTRONIC DIGITAL THERMOMETER
Applicant
PHILIP J. TEDERS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PHILIP J. TEDERS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.2200
Classification Product Code
KPD  
Date Received11/17/1980
Decision Date 12/16/1980
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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