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FDA 510(k)

EXCELSIOR SINGLE LEAD DISPENSING SET

K-Number: K913804 · 1992-02-11

ApplicantExcel Medical, Inc.
Decision Date1992-02-11
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXCELSIOR SINGLE LEAD DISPENSING SET is the device name listed in this FDA 510(k) record. The listed applicant is Excel Medical, Inc.. It received FDA 510(k) clearance on 1992-02-11 under 510(k) number K913804. 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 EXCELSIOR SINGLE LEAD DISPENSING SET?

EXCELSIOR SINGLE LEAD DISPENSING SET is a medical device that received FDA 510(k) clearance on 1992-02-11. The listed applicant is Excel Medical, Inc.. The 510(k) number is K913804.

When did EXCELSIOR SINGLE LEAD DISPENSING SET receive FDA 510(k) clearance?

EXCELSIOR SINGLE LEAD DISPENSING SET received FDA 510(k) clearance on 1992-02-11, under 510(k) number K913804.

Who is the listed applicant for EXCELSIOR SINGLE LEAD DISPENSING SET?

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

What is the FDA product code for EXCELSIOR SINGLE LEAD DISPENSING SET?

The FDA product code for EXCELSIOR SINGLE LEAD DISPENSING SET is LHI.

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Other records listing Excel Medical, 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.

K932462VENTED NEEDLEK923966SYRINGE ADAPTORK914988500 INFUSERK905116PHARM-ASSIST

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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