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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name masker, tinnitus
510(k) Number K070648
Device Name THE INHIBITOR, MODEL 001
Applicant
MELMEDTRONICS, INC.
1550 NORWOOD DR., SUITE 100
HURST,  TX  76054
Applicant Contact DAVID W HOLMES
Correspondent
MELMEDTRONICS, INC.
1550 NORWOOD DR., SUITE 100
HURST,  TX  76054
Correspondent Contact DAVID W HOLMES
Regulation Number874.3400
Classification Product Code
KLW  
Date Received03/08/2007
Decision Date 06/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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