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FDA 510(k)

ADD-A-VIAL II BINARY CONNECTOR

K-Number: K900865 · 1990-07-11

ApplicantKendall Mcgaw Laboratories, Inc.
Decision Date1990-07-11
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ADD-A-VIAL II BINARY CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Mcgaw Laboratories, Inc.. It received FDA 510(k) clearance on 1990-07-11 under 510(k) number K900865. 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 ADD-A-VIAL II BINARY CONNECTOR?

ADD-A-VIAL II BINARY CONNECTOR is a medical device that received FDA 510(k) clearance on 1990-07-11. The listed applicant is Kendall Mcgaw Laboratories, Inc.. The 510(k) number is K900865.

When did ADD-A-VIAL II BINARY CONNECTOR receive FDA 510(k) clearance?

ADD-A-VIAL II BINARY CONNECTOR received FDA 510(k) clearance on 1990-07-11, under 510(k) number K900865.

Who is the listed applicant for ADD-A-VIAL II BINARY CONNECTOR?

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

What is the FDA product code for ADD-A-VIAL II BINARY CONNECTOR?

The FDA product code for ADD-A-VIAL II BINARY CONNECTOR is LHI.

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Other records listing Kendall Mcgaw Laboratories, 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.

K905611MICRORATE PLUS INTELLIGENT PUMPK905610MICRORATE INTELLIGENT PUMPK904855ADD-A-VIALK904518VOLUMETRIC INFUSION PUMPK903809PROTECTED NEEDLE WITH OR WITHOUT IV SETK901065INFUSION PUMP

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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

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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