ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH

Injector And Syringe, Angiographic

ACIST MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Acist Medical Systems with the FDA for Acist Angiographic Injection System, Model Cl1ooh.

Pre-market Notification Details

Device IDK993774
510k NumberK993774
Device Name:ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
ClassificationInjector And Syringe, Angiographic
Applicant ACIST MEDICAL SYSTEMS 7450 FLYING CLOUDS DR. SUITE 150 Eden Prairie,  MN  55344
ContactCarl M Beaurline
CorrespondentCarl M Beaurline
ACIST MEDICAL SYSTEMS 7450 FLYING CLOUDS DR. SUITE 150 Eden Prairie,  MN  55344
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-08
Decision Date1999-12-07
Summary:summary

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