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FDA 510(k) Application Details - K081781
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device
510(K) Number
K081781
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
LABORIE MEDICAL TECHNOLOGIES, CORP
400 AVE D, STE 10
WILLISTON, VT 05495 US
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Contact
BARBARA MORNET
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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
06/24/2008
Decision Date
07/09/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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