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FDA 510(k)

AMIELLE

K-Number: K983045 · 1998-11-25

ApplicantOwen Mumford USA, Inc.
Decision Date1998-11-25
Product CodeKXP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AMIELLE 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 1998-11-25 under 510(k) number K983045. The device is classified under product code KXP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIELLE?

AMIELLE is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Owen Mumford USA, Inc.. The 510(k) number is K983045.

When did AMIELLE receive FDA 510(k) clearance?

AMIELLE received FDA 510(k) clearance on 1998-11-25, under 510(k) number K983045.

Who is the listed applicant for AMIELLE?

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 AMIELLE?

The FDA product code for AMIELLE is KXP.

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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.K973899UNIFINE PENTIPS

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Related Devices (Code: KXP)

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.

K202542Allura Vaginal StentPmt CorporationK974479SILIMED VAGINAL STENTSilimed, LLCK920633PESSARY FLEXIBLE SILICONE NICHOLSBioteque America, Inc.

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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