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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name holder, head, neurosurgical (skull clamp)
510(K) Number K113748
Device Name IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
Applicant
IMRIS, INC.
100-1370 sony place
winnipeg, mb, 
Contact sanjay shah
Regulation Number882.4460
Classification Product Code
HBL  
Date Received12/21/2011
Decision Date 03/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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