MPS ACACIA POWER INJECTABLE INFUSION SET

Set, Administration, Intravascular

MPS ACACIA

The following data is part of a premarket notification filed by Mps Acacia with the FDA for Mps Acacia Power Injectable Infusion Set.

Pre-market Notification Details

Device IDK090809
510k NumberK090809
Device Name:MPS ACACIA POWER INJECTABLE INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant MPS ACACIA 785 CHALLENGER ST. Brea,  CA  92821
ContactFergie Ferguson
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 Received2009-03-25
Decision Date2009-04-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816513023548 K090809 000
00816513022664 K090809 000
00816513022633 K090809 000
00816513022619 K090809 000
10816513024535 K090809 000
10810080610207 K090809 000

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