TRANQUIL TRI-BTE— 510(k) K061459

Name: FDA 510(k) clearance K061459
Creator: U.S. Food and Drug Administration
Published: 2006-06-30

Substantially Equivalent

General Hearing Instruments, Inc.

FDA 510(k) clearance K061459 for TRANQUIL TRI-BTE, Substantially Equivalent on 2006-06-30. Applicant: General Hearing Instruments, Inc.. Device class: 2.

Clearance details

Applicant: General Hearing Instruments, Inc.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2006-05-26
Decision date: 2006-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: New Orleans, LA, US

Download summary PDF View on FDA.gov ↗

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