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FDA 510(k)

UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET

K-Number: K000592 · 2001-04-12

ApplicantMyco Medical Supplies, Inc.
Decision Date2001-04-12
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET is the device name listed in this FDA 510(k) record. The listed applicant is Myco Medical Supplies, Inc.. It received FDA 510(k) clearance on 2001-04-12 under 510(k) number K000592. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET?

UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET is a medical device that received FDA 510(k) clearance on 2001-04-12. The listed applicant is Myco Medical Supplies, Inc.. The 510(k) number is K000592.

When did UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET receive FDA 510(k) clearance?

UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET received FDA 510(k) clearance on 2001-04-12, under 510(k) number K000592.

Who is the listed applicant for UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET?

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

What is the FDA product code for UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET?

The FDA product code for UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET is FPA.

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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