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FDA 510(k)

IVA SEAL II

K-Number: K812527 · 1981-09-16

ApplicantU.S. Clinical Products, Inc.
Decision Date1981-09-16
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IVA SEAL II is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Clinical Products, Inc.. It received FDA 510(k) clearance on 1981-09-16 under 510(k) number K812527. 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 IVA SEAL II?

IVA SEAL II is a medical device that received FDA 510(k) clearance on 1981-09-16. The listed applicant is U.S. Clinical Products, Inc.. The 510(k) number is K812527.

When did IVA SEAL II receive FDA 510(k) clearance?

IVA SEAL II received FDA 510(k) clearance on 1981-09-16, under 510(k) number K812527.

Who is the listed applicant for IVA SEAL II?

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

What is the FDA product code for IVA SEAL II?

The FDA product code for IVA SEAL II is KPE.

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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