SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT

Injector And Syringe, Angiographic

SCIMED LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Encore Advantage Kit And The Essentials Kit.

Pre-market Notification Details

Device IDK951802
510k NumberK951802
Device Name:SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
ClassificationInjector And Syringe, Angiographic
Applicant SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
ContactDiane M Lowe
CorrespondentDiane M Lowe
SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-19
Decision Date1995-07-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H74904494102 K951802 000
20193489078043 K951802 000

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