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FDA 510(k) Application Details - K090349
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K090349
Device Name
Accelerator, Linear, Medical
Applicant
ORBITAL THERAPY, LLC
11 MYSTIC AVENUE
WINCHESTER, MA 01890 US
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Contact
CHAS BURR
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
02/11/2009
Decision Date
03/09/2009
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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