FDA 510(k) Application Details - K070272

Device Classification Name Electrode, Depth

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510(K) Number K070272
Device Name Electrode, Depth
Applicant CYBERKINETICS NEUROTECHNOLOGY SYSTEMS, INC.
800 LEVANGER LANE
STOUGHTON, WI 53589 US
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Contact Gary Syring
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Regulation Number 882.1330

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Classification Product Code GZL
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Date Received 01/29/2007
Decision Date 08/03/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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