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FDA 510(k) Application Details - K080930
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K080930
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
U-SYSTEM, INC.
110 ROSE ORCHARD WAY
SAN JOSE, CA 95134 US
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Contact
LISA SCOTT
Other 510(k) Applications for this Contact
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
04/02/2008
Decision Date
08/07/2008
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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