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FDA 510(k) Application Details - K152788
Device Classification Name
System, X-Ray, Stationary
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510(K) Number
K152788
Device Name
System, X-Ray, Stationary
Applicant
EOS IMAGING
10 RUE MERCOEUR
PARIS FR
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Contact
MATHIAS BREUIL
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Regulation Number
892.1680
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Classification Product Code
KPR
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More FDA Info for this Product Code
Date Received
09/25/2015
Decision Date
10/21/2015
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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