XOMED MANDIBULAR TRAY— 510(k) K821904

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K821904 for XOMED MANDIBULAR TRAY, Substantially Equivalent on 1982-07-26. Applicant: Xomed, Inc.. Device class: 2.

Clearance details

Applicant: Xomed, Inc.
Product code: Code JAZ
Device class: Class 2
Regulation: 21 CFR 874.3695
Advisory panel: Ear, Nose, Throat
Date received: 1982-06-28
Decision date: 1982-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arnold, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAZ

K901923 — INVOTEC POLY-MESH MANDIBULAR TRAY1990-10-31

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K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES2000-06-09

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