CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET

Set, Administration, Intravascular

SMITHS MEDICAL MD, INC.

The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Cadd Administration Set With Flow Stop, Medication Cassette Reservoir With Flow Stop And Extension Set.

Pre-market Notification Details

Device IDK040636
510k NumberK040636
Device Name:CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
ClassificationSet, Administration, Intravascular
Applicant SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
ContactPatricia A Laforte
CorrespondentPatricia A Laforte
SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-10
Decision Date2004-05-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35019517184239 K040636 000
35019517191824 K040636 000
30610586029657 K040636 000

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