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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 K103493
Device Name HEAD FIATION DEVICE (HFD 100)
Applicant
IMRIS, INC.
16809 BRIARDALE ROAD
ROCKVILLE,  MD  20855
Applicant Contact THOMAS M TSKERIS
Correspondent
IMRIS, INC.
16809 BRIARDALE ROAD
ROCKVILLE,  MD  20855
Correspondent Contact THOMAS M TSKERIS
Regulation Number882.4460
Classification Product Code
HBL  
Date Received11/29/2010
Decision Date 03/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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