CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300

Pump, Infusion, Pca

SIMS DELTEC, INC.

The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd-legacy Pca Ambulatory Infusion System, Model 6300.

Pre-market Notification Details

Device IDK982839
510k NumberK982839
Device Name:CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
ClassificationPump, Infusion, Pca
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 CodeMEA  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-12
Decision Date1998-11-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10610586035098 K982839 000
10610586019326 K982839 000
30610586042717 K982839 000
10610586043161 K982839 000
10610586021725 K982839 000
10610586019449 K982839 000
10610586019357 K982839 000

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