Solution Set For Epidural Use

Set, Administration, Intravascular

BAXTER HEALTHCARE CORPORATION

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Solution Set For Epidural Use.

Pre-market Notification Details

Device IDK161323
510k NumberK161323
Device Name:Solution Set For Epidural Use
ClassificationSet, Administration, Intravascular
Applicant BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD Round Lake,  IL  60073
ContactTiffany Lin
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2016-05-11
Decision Date2016-11-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412563713 K161323 000

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