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FDA 510(k) Application Details - K051840
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K051840
Device Name
System, Image Processing, Radiological
Applicant
ST. JUDE MEDICAL
1350 ENERGY LANE. SUITE 110
ST. PAUL, MN 55108 US
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Contact
KAREN MCKELVEY
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
07/07/2005
Decision Date
08/15/2005
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
Y
Expedited Review
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