CYTOSAFE 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 Cytosafe Needle.

Pre-market Notification Details

Device IDK844904
510k NumberK844904
Device Name:CYTOSAFE NEEDLE
ClassificationSet, I.v. Fluid Transfer
Applicant BAXA CORP., SUB. OF COOK GROUP, INC. P.O. BOX 9327 Denver,  CO  80209
ContactMary Steggall
CorrespondentMary Steggall
BAXA CORP., SUB. OF COOK GROUP, INC. P.O. BOX 9327 Denver,  CO  80209
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-17
Decision Date1985-02-22

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