SURESOFT SURGICAL GLOVES

Surgeon's Gloves

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 Suresoft Surgical Gloves.

Pre-market Notification Details

Device IDK940218
510k NumberK940218
Device Name:SURESOFT SURGICAL GLOVES
ClassificationSurgeon's Gloves
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
ContactMarcia C Leatham
CorrespondentMarcia C Leatham
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-14
Decision Date1994-05-16

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