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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 K140845
Device Name LEVO TINNITUS MASKING SOFTWARE DEVICE
Applicant
OTOHARMONICS CORP
1835 MARKET ST.
29TH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact YARMELA PAVLOVIC
Correspondent
OTOHARMONICS CORP
1835 MARKET ST.
29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact YARMELA PAVLOVIC
Regulation Number874.3400
Classification Product Code
KLW  
Date Received04/02/2014
Decision Date 07/18/2014
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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