PRESSURE STOPCOCK/MANIFOLD

Set, Administration, Intravascular

SCIENTIFIC DEVICE MANUFACTURER LLC.

The following data is part of a premarket notification filed by Scientific Device Manufacturer Llc. with the FDA for Pressure Stopcock/manifold.

Pre-market Notification Details

Device IDK960431
510k NumberK960431
Device Name:PRESSURE STOPCOCK/MANIFOLD
ClassificationSet, Administration, Intravascular
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 CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-31
Decision Date1996-10-29
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.