OPUS 2 - FULL CONCHA SERIES - ITE— 510(k) K974211

Substantially Equivalent

Bernafon-Maico, Inc.

FDA 510(k) clearance K974211 for OPUS 2 - FULL CONCHA SERIES - ITE, Substantially Equivalent on 1997-12-15. Applicant: Bernafon-Maico, Inc..

Clearance details

Applicant: Bernafon-Maico, Inc.
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1997-11-10
Decision date: 1997-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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