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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K090957
Device Name BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
Applicant
I2S MICRO IMPLANTABLE SYSTEMS, LLC
800 LEVANGER LANE
STOUGHTON,  WI  53589
Applicant Contact Gary Syring
Correspondent
I2S MICRO IMPLANTABLE SYSTEMS, LLC
800 LEVANGER LANE
STOUGHTON,  WI  53589
Correspondent Contact Gary Syring
Regulation Number882.1835
Classification Product Code
GWL  
Date Received04/06/2009
Decision Date 05/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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