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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 K033621
Device Name NDI PASSIVE SPHERES
Applicant
Northern Digital, Inc.
4 Innovation Dr.
Dundas,  CA L9H 7P3
Applicant Contact NANCY RUTH
Correspondent
Northern Digital, Inc.
4 Innovation Dr.
Dundas,  CA L9H 7P3
Correspondent Contact NANCY RUTH
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/18/2003
Decision Date 01/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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