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FDA 510(k) Application Details - K080196
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K080196
Device Name
System, Image Processing, Radiological
Applicant
CLARIO MEDICAL IMAGING, INC.
1924 FIRST AVE., SUITE 4W
SEATTLE, WA 98101 US
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Contact
CHRIS WOOD
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
01/25/2008
Decision Date
09/05/2008
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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