FDA 510(k) Application Details - K110010

Device Classification Name Electrode, Depth

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510(K) Number K110010
Device Name Electrode, Depth
Applicant BLACKROCK MICROSYSTEMS, INC
391 CHIPETA WAY
SUITE G
SALT LAKE CITY, UT 84108 US
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Contact JERRY ALPERIN
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Regulation Number 882.1330

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Classification Product Code GZL
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Date Received 01/03/2011
Decision Date 02/09/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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