CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM

Pump, Infusion

SIMS DELTEC, INC.

The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd-diplomat Pc Communications System And The Cadd- Ambassador Pump Communications System.

Pre-market Notification Details

Device IDK973917
510k NumberK973917
Device Name:CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM
ClassificationPump, Infusion
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 CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-15
Decision Date1998-01-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00610586019145 K973917 000
10610586026751 K973917 000
10610586021770 K973917 000

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