FDA 510(k)

ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER

K-Number: K081449 · 2008-06-03

Decision Date2008-06-03

Product CodeMMK

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Ultimed, Inc.. It received FDA 510(k) clearance on 2008-06-03 under 510(k) number K081449. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER?

ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER is a medical device that received FDA 510(k) clearance on 2008-06-03. The listed applicant is Ultimed, Inc.. The 510(k) number is K081449.

When did ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER receive FDA 510(k) clearance?

ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER received FDA 510(k) clearance on 2008-06-03, under 510(k) number K081449.

Who is the listed applicant for ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER?

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

What is the FDA product code for ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER?

The FDA product code for ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER is MMK.

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Other records listing Ultimed, Inc. as applicant

K100812ULTICARE DISPOSABLE PEN NEEDLES K080600ULTIMED ULTICARE SAFETY SYRINGE K062702ULTICARE DISPOSABLE SYRINGES AND NEEDLES K050464ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 K033794ULTICARE DISPOSABLE SYRINGE 3 ML/CC K021983ULTI GUARD HOME INSULIN SYRINGE CONTAINER

View all 8 devices →

Related Devices (Code: MMK)

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.