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FDA 510(k)

EQUASHIELD SYSTEM

K-Number: K083152 · 2009-02-02

ApplicantPlastmed, Ltd.
Decision Date2009-02-02
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EQUASHIELD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Plastmed, Ltd.. It received FDA 510(k) clearance on 2009-02-02 under 510(k) number K083152. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EQUASHIELD SYSTEM?

EQUASHIELD SYSTEM is a medical device that received FDA 510(k) clearance on 2009-02-02. The listed applicant is Plastmed, Ltd.. The 510(k) number is K083152.

When did EQUASHIELD SYSTEM receive FDA 510(k) clearance?

EQUASHIELD SYSTEM received FDA 510(k) clearance on 2009-02-02, under 510(k) number K083152.

Who is the listed applicant for EQUASHIELD SYSTEM?

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

What is the FDA product code for EQUASHIELD SYSTEM?

The FDA product code for EQUASHIELD SYSTEM is LHI.

Related Clinical Trials

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Other records listing Plastmed, 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.

K091389EQUALSHIELD LUER LOCK CONNECTOR PAIR

Related Devices (Code: LHI)

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.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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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