TRACHEOLIFE

Condenser, Heat And Moisture (artificial Nose)

MALLINCKRODT MEDICAL

The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Tracheolife.

Pre-market Notification Details

Device IDK941535
510k NumberK941535
Device Name:TRACHEOLIFE
ClassificationCondenser, Heat And Moisture (artificial Nose)
Applicant MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle,  NY  12809
ContactFrank Steciuk
CorrespondentFrank Steciuk
MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle,  NY  12809
Product CodeBYD  
CFR Regulation Number868.5375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-30
Decision Date1994-04-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884522032534 K941535 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.