BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE

Tube, Tracheal (w/wo Connector)

SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Blue Line(r) Pdt(tm) Portex Directional Tube.

Pre-market Notification Details

Device IDK931735
510k NumberK931735
Device Name:BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE
ClassificationTube, Tracheal (w/wo Connector)
Applicant SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene,  NH  03431
ContactTimothy J Talcott
CorrespondentTimothy J Talcott
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene,  NH  03431
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-07
Decision Date1993-05-18

NIH GUDID Devices

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