MIRACLE - EAR (ITE/ITC/CIC)— 510(k) K964419

Substantially Equivalent

Miracle-Ear, Inc.

FDA 510(k) clearance K964419 for MIRACLE - EAR (ITE/ITC/CIC), Substantially Equivalent on 1997-02-04. Applicant: Miracle-Ear, Inc..

Clearance details

Applicant: Miracle-Ear, Inc.
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1996-10-01
Decision date: 1997-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden Valley, MN, US

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