FDA 510(k) Application Details - K032866

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K032866
Device Name System, Tomography, Computed, Emission
Applicant SHARED P.E.T. IMAGING, LLC
710 A STREET, NE
WASHINGTON, DC 20002 US
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Contact RUSS PAGANO
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 09/15/2003
Decision Date 12/12/2003
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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