TRU-TOUCH VINYL, NON-STERILE

Vinyl Patient Examination Glove

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Tru-touch Vinyl, Non-sterile.

Pre-market Notification Details

Device IDK891719
510k NumberK891719
Device Name:TRU-TOUCH VINYL, NON-STERILE
ClassificationVinyl Patient Examination Glove
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
ContactJ Arnsberger
CorrespondentJ Arnsberger
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-21
Decision Date1989-12-05

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