FDA 510(k)

ULTI GUARD HOME INSULIN SYRINGE CONTAINER

K-Number: K021983 · 2002-09-16

Decision Date2002-09-16

Product CodeMMK

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ULTI GUARD HOME INSULIN SYRINGE 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 2002-09-16 under 510(k) number K021983. 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 ULTI GUARD HOME INSULIN SYRINGE CONTAINER?

ULTI GUARD HOME INSULIN SYRINGE CONTAINER is a medical device that received FDA 510(k) clearance on 2002-09-16. The listed applicant is Ultimed, Inc.. The 510(k) number is K021983.

When did ULTI GUARD HOME INSULIN SYRINGE CONTAINER receive FDA 510(k) clearance?

ULTI GUARD HOME INSULIN SYRINGE CONTAINER received FDA 510(k) clearance on 2002-09-16, under 510(k) number K021983.

Who is the listed applicant for ULTI GUARD HOME INSULIN SYRINGE 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 ULTI GUARD HOME INSULIN SYRINGE CONTAINER?

The FDA product code for ULTI GUARD HOME INSULIN SYRINGE CONTAINER is MMK.

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Other records listing Ultimed, Inc. as applicant

K100812ULTICARE DISPOSABLE PEN NEEDLES K080600ULTIMED ULTICARE SAFETY SYRINGE K081449ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER 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

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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.