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FDA 510(k) Application Details - K112460
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K112460
Device Name
Accelerator, Linear, Medical
Applicant
LARSON MEDICAL PRODUCTS, INC.
80 WESTGATE DRIVE
NEWARK, OH 43055 US
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Contact
PETER LARSON
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
08/26/2011
Decision Date
10/07/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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