TRACHEOSTOMY CARE TRAY

Tracheostomy And Nasal Suctioning Kit

WELMED SYSTEMS, INC.

The following data is part of a premarket notification filed by Welmed Systems, Inc. with the FDA for Tracheostomy Care Tray.

Pre-market Notification Details

Device IDK862663
510k NumberK862663
Device Name:TRACHEOSTOMY CARE TRAY
ClassificationTracheostomy And Nasal Suctioning Kit
Applicant WELMED SYSTEMS, INC. P.O. BOX 599 West Swanzey,  NH  03469
ContactDavid B Peters
CorrespondentDavid B Peters
WELMED SYSTEMS, INC. P.O. BOX 599 West Swanzey,  NH  03469
Product CodeLRQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-14
Decision Date1986-07-30

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