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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, auditory, evoked response
510(k) Number K043396
Device Name INTEGRITY, MODEL V500
Applicant
VIVOSONIC, INC.
56 ABERFOYLE CRESCENT
SUITE 620
TORONTO, ON,  CA M8X 2W4
Applicant Contact EDWARD GOSS
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact N.E. DEVINE
Regulation Number882.1900
Classification Product Code
GWJ  
Subsequent Product Code
EWO  
Date Received12/10/2004
Decision Date 01/24/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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