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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 K915791
Device Name CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION
Applicant
Coritechs, Inc.
52 Whitney Ave.
New Haven,  CT  06510
Applicant Contact ERIK G MILLER
Correspondent
Coritechs, Inc.
52 Whitney Ave.
New Haven,  CT  06510
Correspondent Contact ERIK G MILLER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/24/1991
Decision Date 07/10/1992
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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