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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, electrical, evoked response
510(k) Number K040358
Device Name XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
Applicant
EXCEL TECH. LTD.
2568 BRISTOL CIRCLE RD.
OAKVILLE, ONTARIO,  CA L6H 5S1
Applicant Contact CAMERON MAHON
Correspondent
EXCEL TECH. LTD.
2568 BRISTOL CIRCLE RD.
OAKVILLE, ONTARIO,  CA L6H 5S1
Correspondent Contact CAMERON MAHON
Regulation Number882.1870
Classification Product Code
GWF  
Date Received02/13/2004
Decision Date 08/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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