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FDA 510(k)

DUAL CHAMBER TPN CONTAINER

K-Number: K073538 · 2008-03-12

ApplicantB.Braun Medical, Inc.
Decision Date2008-03-12
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DUAL CHAMBER TPN CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2008-03-12 under 510(k) number K073538. 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 DUAL CHAMBER TPN CONTAINER?

DUAL CHAMBER TPN CONTAINER is a medical device that received FDA 510(k) clearance on 2008-03-12. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K073538.

When did DUAL CHAMBER TPN CONTAINER receive FDA 510(k) clearance?

DUAL CHAMBER TPN CONTAINER received FDA 510(k) clearance on 2008-03-12, under 510(k) number K073538.

Who is the listed applicant for DUAL CHAMBER TPN CONTAINER?

The FDA 510(k) record lists B.Braun Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUAL CHAMBER TPN CONTAINER?

The FDA product code for DUAL CHAMBER TPN CONTAINER is KPE.

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Other records listing B.Braun Medical, Inc. 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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