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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 K100843
Device Name ABREU, MODEL 700
Applicant
BRAIN TUNNELGENIX TECHNOLOGIES CORP
8870 RAVELLO CT
NAPLES,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
BRAIN TUNNELGENIX TECHNOLOGIES CORP
8870 RAVELLO CT
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/25/2010
Decision Date 08/17/2010
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
Predetermined Change
Control Plan Authorized		 No
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