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FDA 510(k) Application Details - K193381
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K193381
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
LifeLine Software, Inc.
3304 S Broadway Ave, Suite 200
Tyler, TX 75701 US
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Contact
Craig Laughton
Other 510(k) Applications for this Contact
Regulation Number
892.5050
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Classification Product Code
MUJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/05/2019
Decision Date
12/31/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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