FDA 510(k) Application Details - K062549

Device Classification Name Stimulator, Nerve

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510(K) Number K062549
Device Name Stimulator, Nerve
Applicant EXCEL TECH. LTD.
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO L6H 5S1 CA
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Contact NICOLE LANDREVILLE
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Regulation Number 874.1820

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Classification Product Code ETN
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Date Received 08/30/2006
Decision Date 10/04/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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