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FDA 510(k) Application Details - K990997
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K990997
Device Name
Accelerator, Linear, Medical
Applicant
AKTINA MEDICAL PHYSICS CORP.
360 NORTH ROUTE 9W
CONGERS, NY 10920 US
Other 510(k) Applications for this Company
Contact
JOAN Z ACHAROPOULOS
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
03/25/1999
Decision Date
06/22/1999
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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