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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name aids, speech training for the hearing impaired (ac-powered and patient-contact)
510(k) Number K091682
Device Name LSVT C OR LSVT COMPANION, MODEL V.1
Applicant
LSVT GLOBAL, LLC
6900 E SUNRISE DRIVE
SUITE 120 #241
TUCSON,  AZ  85750
Applicant Contact DAVID H MCFARLAND
Correspondent
LSVT GLOBAL, LLC
6900 E SUNRISE DRIVE
SUITE 120 #241
TUCSON,  AZ  85750
Correspondent Contact DAVID H MCFARLAND
Classification Product Code
LEZ  
Date Received06/10/2009
Decision Date 08/20/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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