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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
Recalls CDRH Recalls
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