UNOMEDICAL MONICA INFUSION SET

Set, Administration, Intravascular

UNOMEDICAL A/S

The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Unomedical Monica Infusion Set.

Pre-market Notification Details

Device IDK032854
510k NumberK032854
Device Name:UNOMEDICAL MONICA INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant UNOMEDICAL A/S AAHOLMVEJ 1-3, OSTED Roskilde,  DK Dk-4000
ContactJohn M Lindskog
CorrespondentJohn M Lindskog
UNOMEDICAL A/S AAHOLMVEJ 1-3, OSTED Roskilde,  DK Dk-4000
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-12
Decision Date2003-10-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850050080268 K032854 000
00850050080251 K032854 000

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