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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 K012974
Device Name PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007
Applicant
PRIZM MEDICAL, INC.
5536 TROWBRIDGE DR.
DUNWOODY,  GA  30338
Applicant Contact CATHRYN N CAMBRIA
Correspondent
PRIZM MEDICAL, INC.
5536 TROWBRIDGE DR.
DUNWOODY,  GA  30338
Correspondent Contact CATHRYN N CAMBRIA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/05/2001
Decision Date 07/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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