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510(k) K150171

Tinnitus Sound Generator Module by Gn Resound A/S — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2015
Date Received
January 26, 2015
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

Other clearances by Gn Resound A/S

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  • K073636 — TINNITUS SOUND GENERATOR MODULE (March 13, 2008)

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