FDA 510(k) Application Details - K980914

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K980914
Device Name System, Tomography, Computed, Emission
Applicant EMORY UNIVERSITY
1510 CLIFTON RD. N.E.
G65 ROLLINS RESEARCH CENTER
ATLANTA, GA 30322 US
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Contact ERNEST V GARCIA
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 03/11/1998
Decision Date 06/04/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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