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FDA 510(k)

MODIFIED EVA-MIX AND DI-MIX BAGS

K-Number: K880506 · 1988-05-20

ApplicantGil-Med Industries C/O Kegan & Kegan, Ltd.
Decision Date1988-05-20
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFIED EVA-MIX AND DI-MIX BAGS is the device name listed in this FDA 510(k) record. The listed applicant is Gil-Med Industries C/O Kegan & Kegan, Ltd.. It received FDA 510(k) clearance on 1988-05-20 under 510(k) number K880506. 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 MODIFIED EVA-MIX AND DI-MIX BAGS?

MODIFIED EVA-MIX AND DI-MIX BAGS is a medical device that received FDA 510(k) clearance on 1988-05-20. The listed applicant is Gil-Med Industries C/O Kegan & Kegan, Ltd.. The 510(k) number is K880506.

When did MODIFIED EVA-MIX AND DI-MIX BAGS receive FDA 510(k) clearance?

MODIFIED EVA-MIX AND DI-MIX BAGS received FDA 510(k) clearance on 1988-05-20, under 510(k) number K880506.

Who is the listed applicant for MODIFIED EVA-MIX AND DI-MIX BAGS?

The FDA 510(k) record lists Gil-Med Industries C/O Kegan & Kegan, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED EVA-MIX AND DI-MIX BAGS?

The FDA product code for MODIFIED EVA-MIX AND DI-MIX BAGS is KPE.

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Other records listing Gil-Med Industries C/O Kegan & Kegan, Ltd. 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.

K870274DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINERK861862DIETO CONTAINER FOR ENTERAL NUTRITIONK841597GIL-MED PARENTERAL NUTRITION OR MEDICINEK841224URO-MALE INCONTINENCE CATHETERK840915DIMIX CONTAINER FOR PARNETERAL NUTRITK840916DIETO CONTAINER FOR ENTERNAL NUTRIT

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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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