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FDA 510(k) Application Details - K133993
Device Classification Name
System, X-Ray, Angiographic
More FDA Info for this Device
510(K) Number
K133993
Device Name
System, X-Ray, Angiographic
Applicant
PIE MEDICAL IMAGING
PHILIPSWEG 1
MAASTRICHT, LIMBURG 6227 AJ NL
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Contact
Florie Daniels
Other 510(k) Applications for this Contact
Regulation Number
892.1600
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Classification Product Code
IZI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2013
Decision Date
03/25/2014
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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