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FDA 510(k)

PHARM-ASSIST

K-Number: K905116 · 1991-04-25

ApplicantExcel Medical, Inc.
Decision Date1991-04-25
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PHARM-ASSIST 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 1991-04-25 under 510(k) number K905116. 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 PHARM-ASSIST?

PHARM-ASSIST is a medical device that received FDA 510(k) clearance on 1991-04-25. The listed applicant is Excel Medical, Inc.. The 510(k) number is K905116.

When did PHARM-ASSIST receive FDA 510(k) clearance?

PHARM-ASSIST received FDA 510(k) clearance on 1991-04-25, under 510(k) number K905116.

Who is the listed applicant for PHARM-ASSIST?

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 PHARM-ASSIST?

The FDA product code for PHARM-ASSIST 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 INFUSERK913804EXCELSIOR SINGLE LEAD DISPENSING SET

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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