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FDA 510(k) Application Details - K993893
Device Classification Name
System, Tomography, Computed, Emission
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510(K) Number
K993893
Device Name
System, Tomography, Computed, Emission
Applicant
MEDX, INC.
3456 NORTH RIDGE AVE., #100
ARLINGTON HEIGHTS, IL 60004 US
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Contact
FLOYD ROWAN
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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
11/16/1999
Decision Date
02/10/2000
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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