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510(k) K132965

SOLACE SOUND GENERATORS by Amplisound Hearing Products & Services — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2014
Date Received
September 20, 2013
Clearance Type
Abbreviated
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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