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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 Dr.
Suite 120 #241
Tucson,  AZ  85750
Applicant Contact DAVID H MCFARLAND
Correspondent
Lsvt Global, LLC
6900 E Sunrise Dr.
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
Predetermined Change
Control Plan Authorized		 No
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