MODIFICATION TO LASER-SHIELD II

Tube, Tracheal (w/wo Connector)

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Modification To Laser-shield Ii.

Pre-market Notification Details

Device IDK993582
510k NumberK993582
Device Name:MODIFICATION TO LASER-SHIELD II
ClassificationTube, Tracheal (w/wo Connector)
Applicant XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
ContactRoy Berens
CorrespondentRoy Berens
XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-22
Decision Date2000-01-20
Summary:summary

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