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510(k) K041302

Device
REFUGE SOUND GENERATOR
Applicant
Micro-Ear Technology, Inc.
510(k) number
K041302
Product code
KLW
Decision
Substantially Equivalent (SESE)
Decision date
2004-07-01
Date received
2004-05-14
Regulation
874.3400
Classification name
Masker, Tinnitus
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DEBORAH SHAFFER
Address
3500 Holly Ln. N., #10 Plymouth MN US 55447 55447

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K163094TinniLogic Mobile Tinnitus Management DeviceJiangsu Betterlife Medical Co., Ltd.2017-05-17
K161562Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc.2016-09-28
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K151558Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro SystemNeurotherapies Reset GmbH2016-01-20
K151719REVE134Kw Ear Lab, Inc.2015-10-09
K150014SerenitySanuthera, Inc.2015-07-27