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510(k) K111293

SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM by Soundcure, Inc. — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2011
Date Received
May 6, 2011
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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