SHARP II HELIX HEARING AID— 510(k) K941295

Substantially Equivalent

Miracle-Ear, Inc.

FDA 510(k) clearance K941295 for SHARP II HELIX HEARING AID, Substantially Equivalent on 1994-06-17. Applicant: Miracle-Ear, Inc..

Clearance details

Applicant: Miracle-Ear, Inc.
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1994-03-17
Decision date: 1994-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden Valley, MN, US

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