CONCEPT ENDOTRACHEAL TUBE

Tube, Tracheal (w/wo Connector)

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Endotracheal Tube.

Pre-market Notification Details

Device IDK801213
510k NumberK801213
Device Name:CONCEPT ENDOTRACHEAL TUBE
ClassificationTube, Tracheal (w/wo Connector)
Applicant CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-05-20
Decision Date1980-05-28

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