ENDOTRACHEAL TUBE STYLET

Stylet, Tracheal Tube

EASTMED ENTERPRISES INC.

The following data is part of a premarket notification filed by Eastmed Enterprises Inc. with the FDA for Endotracheal Tube Stylet.

Pre-market Notification Details

Device IDK921128
510k NumberK921128
Device Name:ENDOTRACHEAL TUBE STYLET
ClassificationStylet, Tracheal Tube
Applicant EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton,  NJ  08053
ContactRathin Putatunda
CorrespondentRathin Putatunda
EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton,  NJ  08053
Product CodeBSR  
CFR Regulation Number868.5790 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-10
Decision Date1992-06-02

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