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FDA 510(k) Application Details - K031779
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K031779
Device Name
System, Image Processing, Radiological
Applicant
CONFIRMA, INC.
821 KIRKLAND AVE.
KIRKLAND, WA 98033-6318 US
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Contact
PATRICIA A MILBANK
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/10/2003
Decision Date
08/06/2003
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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