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FDA 510(k) Application Details - K103597
Device Classification Name
System, X-Ray, Mobile
More FDA Info for this Device
510(K) Number
K103597
Device Name
System, X-Ray, Mobile
Applicant
AGFA HEALTHCARE N.V.
10 S ACADEMY STREET
GREENVILLE, SC 29601 US
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Contact
PHIL CUSCUNA
Other 510(k) Applications for this Contact
Regulation Number
892.1720
More FDA Info for this Regulation Number
Classification Product Code
IZL
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More FDA Info for this Product Code
Date Received
12/08/2010
Decision Date
01/03/2011
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
Y
Expedited Review
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