CONTROL SYRINGE

Injector And Syringe, Angiographic

SCIENTIFIC DEVICE MANUFACTURER LLC.

The following data is part of a premarket notification filed by Scientific Device Manufacturer Llc. with the FDA for Control Syringe.

Pre-market Notification Details

Device IDK960430
510k NumberK960430
Device Name:CONTROL SYRINGE
ClassificationInjector And Syringe, Angiographic
Applicant SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael,  CA  94901
ContactRichard C Ball
CorrespondentRichard C Ball
SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael,  CA  94901
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-31
Decision Date1996-08-06
Summary:summary

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