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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, ventricular
510(k) Number K102101
Device Name SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
Applicant
SURGIVISION, INC.
5 MUSICK
IRVINE,  CA  92618
Applicant Contact EDWARD WADDELL
Correspondent
SURGIVISION, INC.
5 MUSICK
IRVINE,  CA  92618
Correspondent Contact EDWARD WADDELL
Regulation Number882.4060
Classification Product Code
HCD  
Date Received07/27/2010
Decision Date 01/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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