PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

Tube Tracheostomy And Tube Cuff

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 Portex Adjustable Flange Tracheostomy Tube.

Pre-market Notification Details

Device IDK962175
510k NumberK962175
Device Name:PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
ClassificationTube Tracheostomy And Tube Cuff
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 CodeJOH  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-05
Decision Date1997-01-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35019315016169 K962175 000
35019315015865 K962175 000
35019315015872 K962175 000
35019315016107 K962175 000
35019315016114 K962175 000
35019315016121 K962175 000
35019315016138 K962175 000
35019315016145 K962175 000
55019315016156 K962175 000
35019315015858 K962175 000

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