FDA 510(k) Application Details - K130497

Device Classification Name Motor, Drill, Electric

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510(K) Number K130497
Device Name Motor, Drill, Electric
Applicant LINVATEC CORPORATION D/B/A CONMED LINVATEC
11311 Concept Boulevard
LARGO, FL 33773 US
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Contact JONATHAN WERNER
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Regulation Number 882.4360

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Classification Product Code HBC
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Date Received 02/26/2013
Decision Date 03/29/2013
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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