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FDA 510(k)

ALL-IN-ONE CONTAINER

K-Number: K090096 · 2009-01-30

ApplicantBaxter Healthcare Corporation
Decision Date2009-01-30
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALL-IN-ONE CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2009-01-30 under 510(k) number K090096. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALL-IN-ONE CONTAINER?

ALL-IN-ONE CONTAINER is a medical device that received FDA 510(k) clearance on 2009-01-30. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K090096.

When did ALL-IN-ONE CONTAINER receive FDA 510(k) clearance?

ALL-IN-ONE CONTAINER received FDA 510(k) clearance on 2009-01-30, under 510(k) number K090096.

Who is the listed applicant for ALL-IN-ONE CONTAINER?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALL-IN-ONE CONTAINER?

The FDA product code for ALL-IN-ONE CONTAINER is KPE.

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Other records listing Baxter Healthcare Corporation as applicant

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Related Devices (Code: KPE)

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.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AGK252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , 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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