VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)

Tubes, Vacuum Sample, With Anticoagulant

BECTON DICKINSON VACUTAINER SYSTEMS

The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Vacutainer Brand Plus Tube With Edta Anticoagulant(multiple).

Pre-market Notification Details

Device IDK971449
510k NumberK971449
Device Name:VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
ClassificationTubes, Vacuum Sample, With Anticoagulant
Applicant BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes,  NJ  07417 -1885
ContactJohn A Schalago
CorrespondentJohn A Schalago
BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes,  NJ  07417 -1885
Product CodeGIM  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-21
Decision Date1997-06-17
Summary:summary

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