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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 K964229
Device Name REGULUS NAVIGATOR
Applicant
Compass Intl., Inc.
919 37th Ave., NW,
Cascade Business Park
Rochester,  MN  55901
Applicant Contact DEBRAH A FISHER
Correspondent
Compass Intl., Inc.
919 37th Ave., NW,
Cascade Business Park
Rochester,  MN  55901
Correspondent Contact DEBRAH A FISHER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/23/1996
Decision Date 08/19/1997
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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