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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 K822435
Device Name MEDI-THERM SKIN THERMOMETER
Applicant
EVEREST INTERSCIENCE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EVEREST INTERSCIENCE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/13/1982
Decision Date 09/22/1982
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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