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FDA 510(k)

FORMULATION PREPARATION DEVICE

K-Number: K955398 · 1996-04-04

ApplicantB.Braun Medical, Inc.
Decision Date1996-04-04
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FORMULATION PREPARATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 1996-04-04 under 510(k) number K955398. 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 FORMULATION PREPARATION DEVICE?

FORMULATION PREPARATION DEVICE is a medical device that received FDA 510(k) clearance on 1996-04-04. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K955398.

When did FORMULATION PREPARATION DEVICE receive FDA 510(k) clearance?

FORMULATION PREPARATION DEVICE received FDA 510(k) clearance on 1996-04-04, under 510(k) number K955398.

Who is the listed applicant for FORMULATION PREPARATION DEVICE?

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

What is the FDA product code for FORMULATION PREPARATION DEVICE?

The FDA product code for FORMULATION PREPARATION DEVICE is LHI.

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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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