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FDA 510(k) Application Details - K062639
Device Classification Name
Couch, Radiation Therapy, Powered
More FDA Info for this Device
510(K) Number
K062639
Device Name
Couch, Radiation Therapy, Powered
Applicant
MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA
FEYERABENDSTRASSE 13-15
SCHWABMUNCHEN 86830 DE
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Contact
MICHAEL WOLFF
Other 510(k) Applications for this Contact
Regulation Number
892.5770
More FDA Info for this Regulation Number
Classification Product Code
JAI
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More FDA Info for this Product Code
Date Received
09/06/2006
Decision Date
09/21/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
Y
Expedited Review
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