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Manufacturers
US
Soundcure, Inc.
Medical Device Manufacturer
·
US , San Jose , CA
Soundcure, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2011
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Soundcure, Inc.
Ear, Nose, Throat
✕
2
devices
1-2 of 2
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Cleared
Apr 13, 2015
SoundCure Serenade Tinnitus Treatment System
K150065
·
KLW
Ear, Nose, Throat
·
90d
Cleared
Aug 24, 2011
SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
K111293
·
KLW
Ear, Nose, Throat
·
110d
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Ear, Nose, Throat
2