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FDA 510(k) Application Details - K071870
Device Classification Name
Couch, Radiation Therapy, Powered
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510(K) Number
K071870
Device Name
Couch, Radiation Therapy, Powered
Applicant
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
FEYERABENDSTRASSE 13-15
SCHWABMUNCHEN 86830 DE
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Contact
MICHAEL WOLFF
Other 510(k) Applications for this Contact
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
07/06/2007
Decision Date
07/08/2007
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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