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510(k) K260614

Tinnitus Therapy by Sivantos GmbH — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2026
Date Received
February 25, 2026
Clearance Type
Special
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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