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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 K994421
Device Name SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION
Applicant
Surgical Navigation Specialists, Inc.
6509 Airport Rd.
Mississauga Ontario,  CA L4V 1S7
Applicant Contact CAROL NAKAGAWA
Correspondent
Surgical Navigation Specialists, Inc.
6509 Airport Rd.
Mississauga Ontario,  CA L4V 1S7
Correspondent Contact CAROL NAKAGAWA
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/29/1999
Decision Date 02/23/2000
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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