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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 K090190
Device Name WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM
Applicant
Nuclemed S.A.
56b Shadowbrook Dr.
Hudson,  NH  03051
Applicant Contact RAYMOND KELLY
Correspondent
Nuclemed S.A.
56b Shadowbrook Dr.
Hudson,  NH  03051
Correspondent Contact RAYMOND KELLY
Regulation Number882.4560
Classification Product Code
HAW  
Date Received01/26/2009
Decision Date 10/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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