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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K860240
Device Name CNS-EP SYSTEM AND EP 1.0 SOFTWARE
Applicant
Cns, Inc.
7090 Shady Oak Rd.
Eden Prairie,  MN  55344
Applicant Contact DANIEL E COHEN,M.D.
Correspondent
Cns, Inc.
7090 Shady Oak Rd.
Eden Prairie,  MN  55344
Correspondent Contact DANIEL E COHEN,M.D.
Regulation Number882.1870
Classification Product Code
GWF  
Date Received01/23/1986
Decision Date 04/17/1986
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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