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510(k) K161562

Sound Options Tinnitus Treatment by Sound Options Tinnitus Treatments, Inc. — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2016
Date Received
June 6, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Masker, Tinnitus
Device Class
Class II
Regulation Number
874.3400
Review Panel
EN
Submission Type

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