FDA 510(k)

PHLEBOTOMY UNIT SHARPS A GATOR

K-Number: K944114 · 1994-12-02

Decision Date1994-12-02

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PHLEBOTOMY UNIT SHARPS A GATOR is the device name listed in this FDA 510(k) record. The listed applicant is Devon Industries, Inc.. It received FDA 510(k) clearance on 1994-12-02 under 510(k) number K944114. 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 PHLEBOTOMY UNIT SHARPS A GATOR?

PHLEBOTOMY UNIT SHARPS A GATOR is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is Devon Industries, Inc.. The 510(k) number is K944114.

When did PHLEBOTOMY UNIT SHARPS A GATOR receive FDA 510(k) clearance?

PHLEBOTOMY UNIT SHARPS A GATOR received FDA 510(k) clearance on 1994-12-02, under 510(k) number K944114.

Who is the listed applicant for PHLEBOTOMY UNIT SHARPS A GATOR?

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

What is the FDA product code for PHLEBOTOMY UNIT SHARPS A GATOR?

The FDA product code for PHLEBOTOMY UNIT SHARPS A GATOR is FMI.

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Other records listing Devon Industries, Inc. as applicant

K961993BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)K954015ABG POINT LOK NEEDLE PROTECTION DEVICE K946289DEVONS POINT LOK NEEDLE PROTECTION DEVICE K945197THE SHARPS COLLECTION AND DISPOSAL SYSTEM K943892POINT OF USE SHARPS A GATOR K945485ABG NEEDLE PROTECTION

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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.