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FDA 510(k) Application Details - K003779
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K003779
Device Name
Accelerator, Linear, Medical
Applicant
ARPLAY MEDICAL S.A.
1, ROUTE DE CITEAUX
IZEURE, COTE D'OR 21110 FR
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Contact
RICHARD BORGI
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
IYE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/07/2000
Decision Date
07/12/2001
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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