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FDA 510(k)

OWEN MUMFORD 3ML AUTOPEN

K-Number: K983974 · 1998-12-21

ApplicantOwen Mumford USA, Inc.
Decision Date1998-12-21
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OWEN MUMFORD 3ML AUTOPEN 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 1998-12-21 under 510(k) number K983974. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OWEN MUMFORD 3ML AUTOPEN?

OWEN MUMFORD 3ML AUTOPEN is a medical device that received FDA 510(k) clearance on 1998-12-21. The listed applicant is Owen Mumford USA, Inc.. The 510(k) number is K983974.

When did OWEN MUMFORD 3ML AUTOPEN receive FDA 510(k) clearance?

OWEN MUMFORD 3ML AUTOPEN received FDA 510(k) clearance on 1998-12-21, under 510(k) number K983974.

Who is the listed applicant for OWEN MUMFORD 3ML AUTOPEN?

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 OWEN MUMFORD 3ML AUTOPEN?

The FDA product code for OWEN MUMFORD 3ML AUTOPEN is FMF.

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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)K983994UNIFINEK982275RAPPORT V.T.D.K983045AMIELLEK973899UNIFINE PENTIPS

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Related Devices (Code: FMF)

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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