CRESCENT TINNITUS RETAINING SOUND GENERATOR— 510(k) K030180

Name: FDA 510(k) clearance K030180
Creator: U.S. Food and Drug Administration
Published: 2003-09-17

Substantially Equivalent

Starkey Laboratories, Inc.

FDA 510(k) clearance K030180 for CRESCENT TINNITUS RETAINING SOUND GENERATOR, Substantially Equivalent on 2003-09-17. Applicant: Starkey Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Starkey Laboratories, Inc.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2003-01-17
Decision date: 2003-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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