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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name neurological stereotaxic instrument, real-time intraoperative mri
510(k) Number K100836
Device Name CLEARPOINT SYSTEM
Applicant
SURGIVISION, INC.
COLUMBIA SQUARE
555 THIRTEENTH ST, NW
WASHINGTON,  DC  20004
Applicant Contact JOHN J SMITH M.D., J.D.
Correspondent
SURGIVISION, INC.
COLUMBIA SQUARE
555 THIRTEENTH ST, NW
WASHINGTON,  DC  20004
Correspondent Contact JOHN J SMITH M.D., J.D.
Regulation Number882.4560
Classification Product Code
ORR  
Subsequent Product Code
LNH  
Date Received03/24/2010
Decision Date 06/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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