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FDA 510(k) Application Details - K014081
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K014081
Device Name
Accelerator, Linear, Medical
Applicant
AKTINA MEDICAL PHYSICS CORP.
360 NORTH ROUTE 9W
CONGERS, NY 10920 US
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Contact
JOAN KACHAROPOULOS
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
12/11/2001
Decision Date
03/05/2002
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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