CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER

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, Cadd 250ml Flexible Medication Reservoir, Modified Securit Shell, Security Shell Adapter.

Pre-market Notification Details

Device IDK990083
510k NumberK990083
Device Name:CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER
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 Received1999-01-11
Decision Date1999-02-12
Summary:summary

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