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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K002712
Device Name THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F
Applicant
S.A.A.T., LTD.
117 AHUZAH ST.
PUSH-MED LTD
RA'ANANNA,  IL 43373
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
S.A.A.T., LTD.
117 AHUZAH ST.
PUSH-MED LTD
RA'ANANNA,  IL 43373
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/31/2000
Decision Date 02/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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