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FDA 510(k) Application Details - K041701
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K041701
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
AGFA CORP.
10 SOUTH ACADEMY ST.
GREENVILLE, SC 29601 US
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Contact
JEFFERY A JEDLICKA
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
06/22/2004
Decision Date
07/22/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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