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FDA 510(k) Application Details - K192102
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K192102
Device Name
Accelerator, Linear, Medical
Applicant
Aktina Medical Corporation
360 North Route 9W
Congers, NY 10920 US
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Contact
Tony Spaccarotella
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
IYE
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More FDA Info for this Product Code
Date Received
08/05/2019
Decision Date
09/25/2019
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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