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FDA 510(k) Application Details - K112768
Device Classification Name
System, Radiation Therapy, Charged-Particle, Medical
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510(K) Number
K112768
Device Name
System, Radiation Therapy, Charged-Particle, Medical
Applicant
CALYPSO MEDICAL TECHNOLOGIES INC
2101 FOURTH AVE
SUITE 500
SEATTLE, WA 98121 US
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Contact
MARCIA PAGE
Other 510(k) Applications for this Contact
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
09/22/2011
Decision Date
11/18/2011
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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