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FDA 510(k) Application Details - K083061
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K083061
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
ELLEX, INC.
9940 BUSINESS PARK DR.
SUITE 165
SACRAMENTO, CA 95827 US
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Contact
TOM DAVIS
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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
10/14/2008
Decision Date
01/09/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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