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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 K111073
Device Name SURGIVISION INC. CLEARPOINT SYSTEM
Applicant
Surgi-Vision, Inc.
5 Musick
Irvine,  CA  92618
Applicant Contact EDWARD WADDELL
Correspondent
Surgi-Vision, Inc.
5 Musick
Irvine,  CA  92618
Correspondent Contact EDWARD WADDELL
Regulation Number882.4560
Classification Product Code
ORR  
Subsequent Product Code
LNH  
Date Received04/18/2011
Decision Date 06/22/2011
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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