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FDA 510(k)

AUTOJECT MINI

K-Number: K953735 · 1995-11-08

ApplicantOwen Mumford USA, Inc.
Decision Date1995-11-08
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTOJECT MINI is the device name listed in this FDA 510(k) record. The listed applicant is Owen Mumford USA, Inc.. It received FDA 510(k) clearance on 1995-11-08 under 510(k) number K953735. 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 AUTOJECT MINI?

AUTOJECT MINI is a medical device that received FDA 510(k) clearance on 1995-11-08. The listed applicant is Owen Mumford USA, Inc.. The 510(k) number is K953735.

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

AUTOJECT MINI received FDA 510(k) clearance on 1995-11-08, under 510(k) number K953735.

Who is the listed applicant for AUTOJECT MINI?

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

What is the FDA product code for AUTOJECT MINI?

The FDA product code for AUTOJECT MINI is KZH.

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Other records listing Owen Mumford USA, Inc. 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.

K013362AUTOJECT 2K993385AUTOJET 2 (NON-FIXED NEEDLE TYPE)K983994UNIFINEK983974OWEN MUMFORD 3ML AUTOPENK982275RAPPORT V.T.D.K983045AMIELLE

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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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