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FDA 510(k)

TRANSFER NEEDLE

K-Number: K854556 · 1986-01-16

ApplicantSoma Intl., Inc.
Decision Date1986-01-16
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRANSFER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Soma Intl., Inc.. It received FDA 510(k) clearance on 1986-01-16 under 510(k) number K854556. 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 TRANSFER NEEDLE?

TRANSFER NEEDLE is a medical device that received FDA 510(k) clearance on 1986-01-16. The listed applicant is Soma Intl., Inc.. The 510(k) number is K854556.

When did TRANSFER NEEDLE receive FDA 510(k) clearance?

TRANSFER NEEDLE received FDA 510(k) clearance on 1986-01-16, under 510(k) number K854556.

Who is the listed applicant for TRANSFER NEEDLE?

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

What is the FDA product code for TRANSFER NEEDLE?

The FDA product code for TRANSFER NEEDLE is LHI.

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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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