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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K070272
Device Name NEUROPORT ELECTRODE
Applicant
Cyberkinetics Neurotechnology Systems, Inc.
800 Levanger Lane
Stoughton,  WI  53589
Applicant Contact Gary Syring
Correspondent
Cyberkinetics Neurotechnology Systems, Inc.
800 Levanger Lane
Stoughton,  WI  53589
Correspondent Contact Gary Syring
Regulation Number882.1330
Classification Product Code
GZL  
Date Received01/29/2007
Decision Date 08/03/2007
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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