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FDA 510(k) Application Details - K091090
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K091090
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
E-WOO TECHNOLOGY
256 NORTH SAM HOUSTON PKWY E.
SUITE 115
HOUSTON, TX 77060 US
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Contact
VINCENT LEE
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Regulation Number
892.1650
More FDA Info for this Regulation Number
Classification Product Code
MQB
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More FDA Info for this Product Code
Date Received
04/16/2009
Decision Date
08/09/2010
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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