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FDA 510(k)

AUTOJECT 2 FOR GLASSY SYRINGE

K-Number: K122837 · 2012-10-15

ApplicantOwen Mumford, Ltd.
Decision Date2012-10-15
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTOJECT 2 FOR GLASSY SYRINGE 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 2012-10-15 under 510(k) number K122837. 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 2 FOR GLASSY SYRINGE?

AUTOJECT 2 FOR GLASSY SYRINGE is a medical device that received FDA 510(k) clearance on 2012-10-15. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K122837.

When did AUTOJECT 2 FOR GLASSY SYRINGE receive FDA 510(k) clearance?

AUTOJECT 2 FOR GLASSY SYRINGE received FDA 510(k) clearance on 2012-10-15, under 510(k) number K122837.

Who is the listed applicant for AUTOJECT 2 FOR GLASSY SYRINGE?

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 AUTOJECT 2 FOR GLASSY SYRINGE?

The FDA product code for AUTOJECT 2 FOR GLASSY SYRINGE is KZH.

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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.

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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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