FDA 510(k) Application Details - K072191

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K072191
Device Name System, Tomography, Computed, Emission
Applicant GVI TECHNOLOGY PARTNERS
1470 ENTERPRISE PKWY.
TWINSBURG, OH 44087 US
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Contact KEVIN M MURROCK
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 08/06/2007
Decision Date 10/25/2007
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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