INTEGRA, CUSTOM IN-THE-EAR HEARING AID— 510(k) K864180

Substantially Equivalent

Bernafon, Inc.

FDA 510(k) clearance K864180 for INTEGRA, CUSTOM IN-THE-EAR HEARING AID, Substantially Equivalent on 1986-11-05. Applicant: Bernafon, Inc..

Clearance details

Applicant: Bernafon, Inc.
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1986-10-27
Decision date: 1986-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountainside, NJ, US

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