FDA 510(k)

K-PACK II NEEDLE - 29G THIN WALL

K-Number: K082820 · 2008-10-23

Decision Date2008-10-23

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

K-PACK II NEEDLE - 29G THIN WALL is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Europe N.V.. It received FDA 510(k) clearance on 2008-10-23 under 510(k) number K082820. 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 K-PACK II NEEDLE - 29G THIN WALL?

K-PACK II NEEDLE - 29G THIN WALL is a medical device that received FDA 510(k) clearance on 2008-10-23. The listed applicant is Terumo Europe N.V.. The 510(k) number is K082820.

When did K-PACK II NEEDLE - 29G THIN WALL receive FDA 510(k) clearance?

K-PACK II NEEDLE - 29G THIN WALL received FDA 510(k) clearance on 2008-10-23, under 510(k) number K082820.

Who is the listed applicant for K-PACK II NEEDLE - 29G THIN WALL?

The FDA 510(k) record lists Terumo Europe N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-PACK II NEEDLE - 29G THIN WALL?

The FDA product code for K-PACK II NEEDLE - 29G THIN WALL is FMI.

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Other records listing Terumo Europe N.V. as applicant

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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.