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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 K935456
Device Name REGULUS MEASUREMENT UNIT
Applicant
COMPASS INTL., INC.
CASCADE BUSINESS PARK
919 37TH AVENUE, N.W.
ROCHESTER,  MN  55901
Applicant Contact BRUCE A KALL
Correspondent
COMPASS INTL., INC.
CASCADE BUSINESS PARK
919 37TH AVENUE, N.W.
ROCHESTER,  MN  55901
Correspondent Contact BRUCE A KALL
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/12/1993
Decision Date 10/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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