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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 K042384
Device Name NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
Applicant
CYBERKINETICS, INC. (CKI)
391 CHIPETA WAY
SUITE G
SALT LAKE CITY,  UT  84108
Applicant Contact BURKE T BARRETT
Correspondent
CYBERKINETICS, INC. (CKI)
391 CHIPETA WAY
SUITE G
SALT LAKE CITY,  UT  84108
Correspondent Contact BURKE T BARRETT
Regulation Number882.1330
Classification Product Code
GZL  
Subsequent Product Code
GWL  
Date Received09/01/2004
Decision Date 03/29/2005
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
Recalls CDRH Recalls
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