RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE

Tube, Tracheal (w/wo Connector)

RUSCH, INC.

The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Reinforced Trachael Tube Cuffed, Sterile.

Pre-market Notification Details

Device IDK955495
510k NumberK955495
Device Name:RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE
ClassificationTube, Tracheal (w/wo Connector)
Applicant RUSCH, INC. TALL PINES PARK Jaffrey,  NH  03452
ContactNeil R Armstrong
CorrespondentNeil R Armstrong
RUSCH, INC. TALL PINES PARK Jaffrey,  NH  03452
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-01
Decision Date1996-06-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
24026704005592 K955495 000
24026704004687 K955495 000
24026704004670 K955495 000
24026704004663 K955495 000
44026704004650 K955495 000
24026704004649 K955495 000
44026704004636 K955495 000
44026704004629 K955495 000
00850056748032 K955495 000
44026704004698 K955495 000
44026704004704 K955495 000
44026704005589 K955495 000
44026704005572 K955495 000
24026704005561 K955495 000
24026704005554 K955495 000
44026704005541 K955495 000
24026704005530 K955495 000
44026704005527 K955495 000
24026704005516 K955495 000
00850056748025 K955495 000

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