SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

COLOPLAST MANUFACTURING US, LLC

The following data is part of a premarket notification filed by Coloplast Manufacturing Us, Llc with the FDA for Self-cath Cs Closed Urinary Catheterization System.

Pre-market Notification Details

Device IDK070939
510k NumberK070939
Device Name:SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
ClassificationTray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Applicant COLOPLAST MANUFACTURING US, LLC 1601 WEST RIVER ROAD Minneapolis,  MN  55411
ContactRebeka Stoltman
CorrespondentRebeka Stoltman
COLOPLAST MANUFACTURING US, LLC 1601 WEST RIVER ROAD Minneapolis,  MN  55411
Product CodeFCM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-04
Decision Date2007-06-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05708932283083 K070939 000
05708932282970 K070939 000
05708932282963 K070939 000
05708932282956 K070939 000
05708932282949 K070939 000
05708932282932 K070939 000
05708932282925 K070939 000
05708932282918 K070939 000
05708932282901 K070939 000
05708932282987 K070939 000
05708932282994 K070939 000
05708932283090 K070939 000
05708932283076 K070939 000
05708932283069 K070939 000
05708932283052 K070939 000
05708932283045 K070939 000
05708932283038 K070939 000
05708932283021 K070939 000
05708932283014 K070939 000
05708932282895 K070939 000

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