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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 Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact JOHN J SMITH M.D., J.D.
Correspondent
Surgivision, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  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
Predetermined Change
Control Plan Authorized		 No
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