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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 K862220
Device Name COMPASS CT STEREOTACTIC ADAPTATION SYSTEM
Applicant
Stereotactic Medical Systems, Inc.
11 Seneca Turpike
New Harford,  NY  13413
Applicant Contact BRUCE A KALL
Correspondent
Stereotactic Medical Systems, Inc.
11 Seneca Turpike
New Harford,  NY  13413
Correspondent Contact BRUCE A KALL
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/11/1986
Decision Date 06/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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