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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
Predetermined Change
Control Plan Authorized		 No
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