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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., N.W.,
CASCADE BUSINESS PARK
ROCHESTER,  MN  55901
Applicant Contact DEBRAH A FISHER
Correspondent
COMPASS INTL., INC.
919 37TH AVE., N.W.,
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
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