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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 K110010
Device Name NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
Applicant
BLACKROCK MICROSYSTEMS, INC
391 CHIPETA WAY
SUITE G
SALT LAKE CITY,  UT  84108
Applicant Contact JERRY ALPERIN
Correspondent
BLACKROCK MICROSYSTEMS, INC
391 CHIPETA WAY
SUITE G
SALT LAKE CITY,  UT  84108
Correspondent Contact JERRY ALPERIN
Regulation Number882.1330
Classification Product Code
GZL  
Date Received01/03/2011
Decision Date 02/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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