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FDA 510(k)

SECURE EVA DUAL CHAMBER MIXING BAG

K-Number: K960581 · 1996-04-30

ApplicantSecure Medical Products, Inc.
Decision Date1996-04-30
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SECURE EVA DUAL CHAMBER MIXING BAG is the device name listed in this FDA 510(k) record. The listed applicant is Secure Medical Products, Inc.. It received FDA 510(k) clearance on 1996-04-30 under 510(k) number K960581. 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 SECURE EVA DUAL CHAMBER MIXING BAG?

SECURE EVA DUAL CHAMBER MIXING BAG is a medical device that received FDA 510(k) clearance on 1996-04-30. The listed applicant is Secure Medical Products, Inc.. The 510(k) number is K960581.

When did SECURE EVA DUAL CHAMBER MIXING BAG receive FDA 510(k) clearance?

SECURE EVA DUAL CHAMBER MIXING BAG received FDA 510(k) clearance on 1996-04-30, under 510(k) number K960581.

Who is the listed applicant for SECURE EVA DUAL CHAMBER MIXING BAG?

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

What is the FDA product code for SECURE EVA DUAL CHAMBER MIXING BAG?

The FDA product code for SECURE EVA DUAL CHAMBER MIXING BAG is KPE.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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