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FDA 510(k) Application Details - K141800
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K141800
Device Name
Accelerator, Linear, Medical
Applicant
SUN NUCLEAR CORPORATION
3275 SUNTREE BOULEVARD
MELBOURNE, FL 32940 US
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Contact
JEFF KAPATOES
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
07/03/2014
Decision Date
09/26/2014
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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