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FDA 510(k)

KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER

K-Number: K061197 · 2006-06-30

ApplicantKawasumi Laboratories, Inc.
Decision Date2006-06-30
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2006-06-30 under 510(k) number K061197. 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 KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER?

KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER is a medical device that received FDA 510(k) clearance on 2006-06-30. The listed applicant is Kawasumi Laboratories, Inc.. The 510(k) number is K061197.

When did KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER receive FDA 510(k) clearance?

KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER received FDA 510(k) clearance on 2006-06-30, under 510(k) number K061197.

Who is the listed applicant for KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER?

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

What is the FDA product code for KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER?

The FDA product code for KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER is KPE.

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Other records listing Kawasumi Laboratories, 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.

K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)K190233K-Shield Advantage Port Access Infusion Set (PAIS)K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemK123344K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)K100720K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBINGK102994K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR

View all 11 devices →

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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