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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 DRIVE
DUNDAS, ONTARIO,  CA L9H 7P3
Applicant Contact NANCY RUTH
Correspondent
NORTHERN DIGITAL, INC.
4 INNOVATION DRIVE
DUNDAS, ONTARIO,  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
Recalls CDRH Recalls
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