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FDA 510(k) Application Details - K072867
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K072867
Device Name
System, X-Ray, Stationary
Applicant
IMIX ADR FINLAND OY
75 ORCHARD SPRING ESTS
WATERBURY, VT 05676 US
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Contact
JAMES TAYLOR
Other 510(k) Applications for this Contact
Regulation Number
892.1680
More FDA Info for this Regulation Number
Classification Product Code
KPR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/05/2007
Decision Date
11/21/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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