CUSTOM IN-THE-EAR— 510(k) K863975

Substantially Equivalent

Gn Danavox, Inc.

FDA 510(k) clearance K863975 for CUSTOM IN-THE-EAR, Substantially Equivalent on 1986-11-07. Applicant: Gn Danavox, Inc..

Clearance details

Applicant: Gn Danavox, Inc.
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1986-10-14
Decision date: 1986-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.