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FDA 510(k) Application Details - K083745
Device Classification Name
System, X-Ray, Angiographic
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510(K) Number
K083745
Device Name
System, X-Ray, Angiographic
Applicant
PAIEON, INC.
22 HAMELACHA ST., P.O.B. 11355
ROSH HAAYIN 48901 IL
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Contact
SHAHAR MANDELBOIM
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Regulation Number
892.1600
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Classification Product Code
IZI
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More FDA Info for this Product Code
Date Received
12/16/2008
Decision Date
02/17/2009
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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