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FDA 510(k) Application Details - K103599
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K103599
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
MERIDIAN MEDICAL SYSTEMS, LLC
325 HARRIS DRIVE
AURORA, OH 44202 US
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Contact
ARIEL MARCIANO
Other 510(k) Applications for this Contact
Regulation Number
892.1650
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Classification Product Code
MQB
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More FDA Info for this Product Code
Date Received
12/08/2010
Decision Date
04/27/2011
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
N
Expedited Review
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