FDA 510(k) Application Details - K083112

Device Classification Name Motor, Drill, Electric

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510(K) Number K083112
Device Name Motor, Drill, Electric
Applicant NAKANISHI, INC.
1425 K STREET, N.W.
SUITE 1100
WASHINGTON, DC 20005 US
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Contact KEITH A BARRITT
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Regulation Number 882.4360

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Classification Product Code HBC
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Date Received 10/21/2008
Decision Date 04/29/2009
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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