CERAVITAL MIDDLE EAR IMPLANT— 510(k) K913619

Name: FDA 510(k) clearance K913619
Creator: U.S. Food and Drug Administration
Published: 1991-10-15

Substantially Equivalent

Friedrichsfeld Medizintechnik AG

FDA 510(k) clearance K913619 for CERAVITAL MIDDLE EAR IMPLANT, Substantially Equivalent on 1991-10-15. Applicant: Friedrichsfeld Medizintechnik AG. Device class: 2.

Clearance details

Applicant: Friedrichsfeld Medizintechnik AG
Product code: Code ETB
Device class: Class 2
Regulation: 21 CFR 874.3450
Advisory panel: Ear, Nose, Throat
Date received: 1991-08-13
Decision date: 1991-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

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