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510(k) K110932

TINNITUS SOUND GENERATOR MODULE by Gn Resound A/S — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2011
Date Received
April 4, 2011
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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