CATHETER TUBING MODIFICATION

Catheter, Intravascular, Diagnostic

JELCO LABORATORIES

The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Catheter Tubing Modification.

Pre-market Notification Details

Device IDK790107
510k NumberK790107
Device Name:CATHETER TUBING MODIFICATION
ClassificationCatheter, Intravascular, Diagnostic
Applicant JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-01-16
Decision Date1979-02-01

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