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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 K871046
Device Name COMPASS STEREOTACTIC POSITIONING SYSTEM
Applicant
Stereotactic Medical Systems, Inc.
11 Seneca Turpike
New Harford,  NY  13413
Applicant Contact KALL, M.S.
Correspondent
Stereotactic Medical Systems, Inc.
11 Seneca Turpike
New Harford,  NY  13413
Correspondent Contact KALL, M.S.
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/17/1987
Decision Date 05/08/1987
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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