FDA 510(k) Application Details - K041220

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K041220
Device Name System, Tomography, Computed, Emission
Applicant GE MEDICAL SYSTEMS
P.O. 414
MILWAUKEE, WI 53188 US
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Contact DAVID DUERSTELER
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 05/10/2004
Decision Date 06/15/2004
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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