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FDA 510(k) Application Details - K071403
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K071403
Device Name
System, X-Ray, Stationary
Applicant
IMAGING DYNAMICS COMPANY LTD.
2340 PEGASUS WAY, NE
SUITE 151
CALGARY T2E 8M5 CA
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Contact
SHIRANTHAN SAMARAPPULI
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
05/21/2007
Decision Date
06/11/2007
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
N
Expedited Review
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