PRN ADAPTER

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

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 Prn Adapter.

Pre-market Notification Details

Device IDK933467
510k NumberK933467
Device Name:PRN ADAPTER
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 9450 SOUTH STATE SREET Sandy,  UT  84070
ContactCharles J Welle
CorrespondentCharles J Welle
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 9450 SOUTH STATE SREET Sandy,  UT  84070
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-16
Decision Date1994-12-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903851107 K933467 000
50382903851145 K933467 000
50382903851121 K933467 000
50382903851114 K933467 000

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