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FDA 510(k) Application Details - K110447
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K110447
Device Name
System, Image Processing, Radiological
Applicant
ULTRASOUND MEDICAL DEVICES, INC.
3917 RESEARCH PARK DRIVE
ANN ARBOR, MI 48108 US
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Contact
PAUL KORTESOJA
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
02/16/2011
Decision Date
05/27/2011
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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