KIT PAK SUCTION CATHETER KIT

Catheters, Suction, Tracheobronchial

KIT PAK, INC.

The following data is part of a premarket notification filed by Kit Pak, Inc. with the FDA for Kit Pak Suction Catheter Kit.

Pre-market Notification Details

Device IDK885131
510k NumberK885131
Device Name:KIT PAK SUCTION CATHETER KIT
ClassificationCatheters, Suction, Tracheobronchial
Applicant KIT PAK, INC. 825 CHASE AVE. Elk Grove Village,  IL  60007
ContactJames S Sanders
CorrespondentJames S Sanders
KIT PAK, INC. 825 CHASE AVE. Elk Grove Village,  IL  60007
Product CodeBSY  
CFR Regulation Number868.6810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-12
Decision Date1989-01-09

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