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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 Cir.
Oakville,  CA L6H 5S1
Applicant Contact NICOLE LANDREVILLE
Correspondent
Excel Tech. , Ltd.
2568 Bristol Cir.
Oakville,  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
Predetermined Change
Control Plan Authorized		 No
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