PISTON SYRINGES

Needle, Hypodermic, Single Lumen

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 Piston Syringes.

Pre-market Notification Details

Device IDK944757
510k NumberK944757
Device Name:PISTON SYRINGES
ClassificationNeedle, Hypodermic, Single Lumen
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 2350 Qume Dr. San Jose,  CA  95131
ContactKaren Rosencrans
CorrespondentKaren Rosencrans
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 2350 Qume Dr. San Jose,  CA  95131
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-27
Decision Date1995-01-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903096065 K944757 000
50382903055543 K944757 000
50382903055581 K944757 000
50382903055598 K944757 000
50382903055611 K944757 000
50382903055642 K944757 000
50382903095921 K944757 000
50382903095938 K944757 000
50382903095945 K944757 000
50382903095952 K944757 000
50382903095969 K944757 000
50382903055536 K944757 000

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