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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
510(k) Number K112469
Device Name GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM
Applicant
Sonowand AS
435 Rice Creek Terrance NE
Fridley,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Sonowand AS
435 Rice Creek Terrance NE
Fridley,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
IYN  
Date Received08/26/2011
Decision Date 03/23/2012
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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