CADD MEDICATION CASSETTE RESERVOIR

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 Medication Cassette Reservoir.

Pre-market Notification Details

Device IDK081156
510k NumberK081156
Device Name:CADD MEDICATION CASSETTE RESERVOIR
ClassificationSet, Administration, Intravascular
Applicant SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
ContactDavid H Short
CorrespondentDavid H Short
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 Received2008-04-23
Decision Date2008-07-18
Summary:summary

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