CERAVITAL CERAMIC EAR CANAL WALL PROSTH— 510(k) K813224

Name: FDA 510(k) clearance K813224
Creator: U.S. Food and Drug Administration
Published: 1982-04-21

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K813224 for CERAVITAL CERAMIC EAR CANAL WALL PROSTH, Substantially Equivalent on 1982-04-21. Applicant: Xomed, Inc.. Device class: 2.

Clearance details

Applicant: Xomed, Inc.
Product code: Code ESF
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 1981-11-09
Decision date: 1982-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arnold, MO, US

Download summary PDF View on FDA.gov ↗

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K891247 — BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC1989-03-29

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K002828 — XPS NITRO SYSTEM2000-10-17
K002897 — TITANIUM MIDDLE EAR PROSTHESES2000-10-11
K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES2000-06-09

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