VENTED I.V. TRANSFER NEEDLE

Set, I.v. Fluid Transfer

BAXA CORP., SUB. OF COOK GROUP, INC.

The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for Vented I.v. Transfer Needle.

Pre-market Notification Details

Device IDK832332
510k NumberK832332
Device Name:VENTED I.V. TRANSFER NEEDLE
ClassificationSet, I.v. Fluid Transfer
Applicant BAXA CORP., SUB. OF COOK GROUP, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-18
Decision Date1983-09-12

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