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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K980914
Device Name EMORY CARDIAC TOOL BOX
Applicant
Emory University
1510 Clifton Rd. NE
G65 Rollins Research Center
Atlanta,  GA  30322
Applicant Contact ERNEST V GARCIA
Correspondent
Emory University
1510 Clifton Rd. NE
G65 Rollins Research Center
Atlanta,  GA  30322
Correspondent Contact ERNEST V GARCIA
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/11/1998
Decision Date 06/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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