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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining, For Neurosurgery
510(k) Number K896156
Device Name COMPASS(TM) STEREOTACTIC RETRACTOR 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 Number882.4800
Classification Product Code
GZT  
Date Received10/24/1989
Decision Date 12/06/1989
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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