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FDA 510(k) Application Details - K051921
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K051921
Device Name
Accelerator, Linear, Medical
Applicant
SUN NUCLEAR CORP.
425-A PINEDA COURT
MELBOURNE, FL 32940 US
Other 510(k) Applications for this Company
Contact
NOEL M DOWNEY
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
07/15/2005
Decision Date
07/27/2005
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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