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FDA 510(k) Application Details - K113086
Device Classification Name
System, Tomography, Computed, Emission
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510(K) Number
K113086
Device Name
System, Tomography, Computed, Emission
Applicant
TEXAS MEDICAL IMAGING CONSULTANTS
4027 UNDERWOOD ST.
HOUSTON, TX 77025 US
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Contact
TINSU PAN
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Regulation Number
892.1200
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Classification Product Code
KPS
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More FDA Info for this Product Code
Date Received
10/18/2011
Decision Date
01/13/2012
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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