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FDA 510(k) Application Details - K092954
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K092954
Device Name
System, Image Processing, Radiological
Applicant
CONFIRMA, INC.
11040 MAIN STREET
SUITE 100
BELLEVUE, WA 98004 US
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Contact
BRENT LEWIS
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/25/2009
Decision Date
11/06/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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