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FDA 510(k) Application Details - K973960
Device Classification Name
System, Radiation Therapy, Charged-Particle, Medical
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510(K) Number
K973960
Device Name
System, Radiation Therapy, Charged-Particle, Medical
Applicant
VICTOREEN, INC.
6000 COCHRAN RD.
SOLON, OH 44139-3395 US
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Contact
LINDA S NASH
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Regulation Number
892.5050
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Classification Product Code
LHN
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More FDA Info for this Product Code
Date Received
10/16/1997
Decision Date
01/14/1998
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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