CADD ADMINISTRATION SET

Set, Administration, Intravascular

SIMS DELTEC, INC.

The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd Administration Set.

Pre-market Notification Details

Device IDK991599
510k NumberK991599
Device Name:CADD ADMINISTRATION SET
ClassificationSet, Administration, Intravascular
Applicant SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
ContactEdward W Numainville
CorrespondentEdward W Numainville
SIMS DELTEC, 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 Received1999-05-10
Decision Date1999-06-15
Summary:summary

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