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FDA 510(k) Application Details - K131489
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device
510(K) Number
K131489
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
TRACTUS CORPORATION
1394 25TH ST. NW
BUFFALO, MN 55313 US
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Contact
MARK JOB
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Regulation Number
892.1560
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Classification Product Code
IYO
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More FDA Info for this Product Code
Date Received
05/23/2013
Decision Date
06/25/2013
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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