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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve
510(k) Number K062549
Device Name XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
Applicant
EXCEL TECH. LTD.
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO,  CA L6H 5S1
Applicant Contact NICOLE LANDREVILLE
Correspondent
EXCEL TECH. LTD.
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO,  CA L6H 5S1
Correspondent Contact NICOLE LANDREVILLE
Regulation Number874.1820
Classification Product Code
ETN  
Date Received08/30/2006
Decision Date 10/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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