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FDA 510(k) Application Details - K180289
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K180289
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
3D Bolus, Inc.
1344 Summer St
Suite 3015
Halifax B3H 0A8 CA
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Contact
Peter Hickey
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
MUJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/01/2018
Decision Date
07/10/2018
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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