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FDA 510(k)

MODIFICATION TO AUTOJECT MINI

K-Number: K000482 · 2000-03-06

ApplicantOwen Mumford, Ltd.
Decision Date2000-03-06
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO AUTOJECT MINI is the device name listed in this FDA 510(k) record. The listed applicant is Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2000-03-06 under 510(k) number K000482. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO AUTOJECT MINI?

MODIFICATION TO AUTOJECT MINI is a medical device that received FDA 510(k) clearance on 2000-03-06. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K000482.

When did MODIFICATION TO AUTOJECT MINI receive FDA 510(k) clearance?

MODIFICATION TO AUTOJECT MINI received FDA 510(k) clearance on 2000-03-06, under 510(k) number K000482.

Who is the listed applicant for MODIFICATION TO AUTOJECT MINI?

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

What is the FDA product code for MODIFICATION TO AUTOJECT MINI?

The FDA product code for MODIFICATION TO AUTOJECT MINI is KZH.

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Other records listing Owen Mumford, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KZH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243232GripMateSynthon Hispania S.L.K213429AccuSert Needle InserterEmed Technologies CorporationK163400Orbit InserterYpsomed AGK160860MiniMed Quick-serterMedtronic MinimedK124026LOBSTER AUTO-INJECTORScandinavian Health LimitedK122837AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.

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.

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