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FDA 510(k)

EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET

K-Number: K890094 · 1989-05-24

ApplicantKells Medical, Inc.
Decision Date1989-05-24
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET is the device name listed in this FDA 510(k) record. The listed applicant is Kells Medical, Inc.. It received FDA 510(k) clearance on 1989-05-24 under 510(k) number K890094. 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 EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET?

EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET is a medical device that received FDA 510(k) clearance on 1989-05-24. The listed applicant is Kells Medical, Inc.. The 510(k) number is K890094.

When did EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET receive FDA 510(k) clearance?

EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET received FDA 510(k) clearance on 1989-05-24, under 510(k) number K890094.

Who is the listed applicant for EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET?

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

What is the FDA product code for EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET?

The FDA product code for EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET is KPE.

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Other records listing Kells Medical, 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.

K926333CPR PLUSK890093PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SETK890095PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK861972DERMISTRIPK844463DERMIDRESSK844072DERMIZIP SKIN CLOSURE DEVICE

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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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