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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 K011059
Device Name INFARED EAR THERMOMETER, MODEL TH8 SERIES
Applicant
RADIANT INNOVATION, INC.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
RADIANT INNOVATION, INC.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/06/2001
Decision Date 09/17/2001
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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