CPR TRACHEOTOMY CARE TRAY

Tube, Tracheostomy (w/wo Connector)

CUSTOM PACK RELIABILITY

The following data is part of a premarket notification filed by Custom Pack Reliability with the FDA for Cpr Tracheotomy Care Tray.

Pre-market Notification Details

Device IDK960205
510k NumberK960205
Device Name:CPR TRACHEOTOMY CARE TRAY
ClassificationTube, Tracheostomy (w/wo Connector)
Applicant CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 Orlando,  FL  32811
ContactRichard L Ellwood
CorrespondentRichard L Ellwood
CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 Orlando,  FL  32811
Product CodeBTO  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-16
Decision Date1996-08-27

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