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FDA 510(k)

I.V. PLASTIC BAG

K-Number: K811233 · 1981-06-17

ApplicantMedi-Plast Intl., Inc.
Decision Date1981-06-17
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I.V. PLASTIC BAG is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Plast Intl., Inc.. It received FDA 510(k) clearance on 1981-06-17 under 510(k) number K811233. 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 I.V. PLASTIC BAG?

I.V. PLASTIC BAG is a medical device that received FDA 510(k) clearance on 1981-06-17. The listed applicant is Medi-Plast Intl., Inc.. The 510(k) number is K811233.

When did I.V. PLASTIC BAG receive FDA 510(k) clearance?

I.V. PLASTIC BAG received FDA 510(k) clearance on 1981-06-17, under 510(k) number K811233.

Who is the listed applicant for I.V. PLASTIC BAG?

The FDA 510(k) record lists Medi-Plast Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.V. PLASTIC BAG?

The FDA product code for I.V. PLASTIC BAG is KPE.

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Other records listing Medi-Plast Intl., 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.

K954284MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)K87358810CC CONTROL SYRINGEK863402MEDI-PLAST DISPOSABLE MANIFOLDK861785FLUOROSCOPE BAND BAGK851489ARTERIAL-VENOUS COMPRESSION DRESSINGK842136STERILE PAN SET

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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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