TRAY, CATHETERIZATION W/ CATHETER

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

CONCORD LABORATORIES, INC.

The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Tray, Catheterization W/ Catheter.

Pre-market Notification Details

Device IDK760128
510k NumberK760128
Device Name:TRAY, CATHETERIZATION W/ CATHETER
ClassificationTray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Applicant CONCORD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFCM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-06-28
Decision Date1976-10-07

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