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FDA 510(k)

OMNIMED I.V. SOLUTION ADMIN. SET

K-Number: K853255 · 1985-08-23

ApplicantOmni Intl., Inc.
Decision Date1985-08-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OMNIMED I.V. SOLUTION ADMIN. SET is the device name listed in this FDA 510(k) record. The listed applicant is Omni Intl., Inc.. It received FDA 510(k) clearance on 1985-08-23 under 510(k) number K853255. 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 OMNIMED I.V. SOLUTION ADMIN. SET?

OMNIMED I.V. SOLUTION ADMIN. SET is a medical device that received FDA 510(k) clearance on 1985-08-23. The listed applicant is Omni Intl., Inc.. The 510(k) number is K853255.

When did OMNIMED I.V. SOLUTION ADMIN. SET receive FDA 510(k) clearance?

OMNIMED I.V. SOLUTION ADMIN. SET received FDA 510(k) clearance on 1985-08-23, under 510(k) number K853255.

Who is the listed applicant for OMNIMED I.V. SOLUTION ADMIN. SET?

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

What is the FDA product code for OMNIMED I.V. SOLUTION ADMIN. SET?

The FDA product code for OMNIMED I.V. SOLUTION ADMIN. SET is FPA.

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Other records listing Omni Intl., 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.

K984066OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIMK984064OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREEK851938OMNIMED SURGICAL GOWNK851654OMNIMED CLAMPK851734OMNIMED SUPERIOR TRANSDUCER PROTECTORK850706F-SERIES IMPLANT

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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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