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FDA 510(k) Application Details - K042861
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K042861
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
PERMEDICS, INC.
1475 SOUTH VICTORIA CT.
SAN BERNARDINO, CA 92408 US
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Contact
JESSICA CONNOR
Other 510(k) Applications for this Contact
Regulation Number
892.5050
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Classification Product Code
MUJ
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More FDA Info for this Product Code
Date Received
10/15/2004
Decision Date
01/12/2005
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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