XOMED THERMAL MYRINGOTOMY SYSTEM

Unit, Cautery, Thermal, Battery-powered

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Thermal Myringotomy System.

Pre-market Notification Details

Device IDK820157
510k NumberK820157
Device Name:XOMED THERMAL MYRINGOTOMY SYSTEM
ClassificationUnit, Cautery, Thermal, Battery-powered
Applicant XOMED, INC. 1318 LONEDELL RD. Arnold,  MO  63010
Product CodeHQP  
CFR Regulation Number886.4115 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-01-19
Decision Date1982-03-02

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