FDA 510(k)

HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE

K-Number: K041399 · 2004-07-28

Decision Date2004-07-28

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2004-07-28 under 510(k) number K041399. 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 HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE?

HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE is a medical device that received FDA 510(k) clearance on 2004-07-28. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K041399.

When did HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE receive FDA 510(k) clearance?

HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE received FDA 510(k) clearance on 2004-07-28, under 510(k) number K041399.

Who is the listed applicant for HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE?

The FDA 510(k) record lists Smiths Medical Asd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE?

The FDA product code for HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE is FMI.

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Related Devices (Code: FMI)

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Official Source

View on FDA Database →

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