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FDA 510(k) Application Details - K112132
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K112132
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
MEDICATECH USA
8870 RAVELLO COURT
NAPLES, FL 34114 US
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Contact
DANIEL KAMM
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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
07/26/2011
Decision Date
11/18/2011
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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