AEROSOL-T

Connector, Airway (extension)

SOUTHMEDIC, INC.

The following data is part of a premarket notification filed by Southmedic, Inc. with the FDA for Aerosol-t.

Pre-market Notification Details

Device IDK863318
510k NumberK863318
Device Name:AEROSOL-T
ClassificationConnector, Airway (extension)
Applicant SOUTHMEDIC, INC. P.O. BOX 1365 Barrie, Ontario Canada,  CA L4m 5r4
ContactLee Mcdonald
CorrespondentLee Mcdonald
SOUTHMEDIC, INC. P.O. BOX 1365 Barrie, Ontario Canada,  CA L4m 5r4
Product CodeBZA  
CFR Regulation Number868.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-26
Decision Date1986-09-11

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.