FDA 510(k)

B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16

K-Number: K002938 · 2000-11-29

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date2000-11-29

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 2000-11-29 under 510(k) number K002938. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16?

B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 is a medical device that received FDA 510(k) clearance on 2000-11-29. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K002938.

When did B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 receive FDA 510(k) clearance?

B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 received FDA 510(k) clearance on 2000-11-29, under 510(k) number K002938.

Who is the listed applicant for B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16?

The FDA product code for B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 is FMI.

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Related Devices (Code: FMI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.