FDA 510(k) Application Details - K132264

Device Classification Name Motor, Drill, Electric

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510(K) Number K132264
Device Name Motor, Drill, Electric
Applicant NAKANISHI, INC.
1201 RICHARDSON DRIVE
SUITE 280
RICHARDSON, TX 75080 US
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Contact DIANE RUTHERFORD
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Regulation Number 882.4360

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Classification Product Code HBC
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Date Received 07/22/2013
Decision Date 12/17/2013
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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