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FDA 510(k) Application Details - K953391
Device Classification Name
System, Radiation Therapy, Charged-Particle, Medical
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510(K) Number
K953391
Device Name
System, Radiation Therapy, Charged-Particle, Medical
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD, CA 94520 US
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Contact
KENNETH MICHAEL
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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
07/19/1995
Decision Date
03/07/1996
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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