TRANQUIL TRI-BTE— 510(k) K061459

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..

Clearance details

Applicant: General Hearing Instruments, Inc.
Product code: Code KLW
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

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