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510(k) K150014

Serenity by Sanuthera, Inc. — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2015
Date Received
January 5, 2015
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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