TWOFER 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 Twofer Needle.

Pre-market Notification Details

Device IDK832347
510k NumberK832347
Device Name:TWOFER 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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20085412478429 K832347 000
50085412478413 K832347 000
50085412478406 K832347 000
50085412478390 K832347 000
00085412478395 K832347 000
00085412478418 K832347 000

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