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FDA 510(k) Application Details - K132084
Device Classification Name
Couch, Radiation Therapy, Powered
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510(K) Number
K132084
Device Name
Couch, Radiation Therapy, Powered
Applicant
MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
1401 8TH STREET SE
ORANGE CITY, IA 51041 US
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Contact
AMANDA STAHLE
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Regulation Number
892.5770
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Classification Product Code
JAI
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More FDA Info for this Product Code
Date Received
07/05/2013
Decision Date
09/26/2013
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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