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FDA 510(k)

SAGE CONTRAST MANAGEMENT SYSTEM

K-Number: K991112 · 1999-09-02

ApplicantSage Laboratories, Inc.
Decision Date1999-09-02
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAGE CONTRAST MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sage Laboratories, Inc.. It received FDA 510(k) clearance on 1999-09-02 under 510(k) number K991112. 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 SAGE CONTRAST MANAGEMENT SYSTEM?

SAGE CONTRAST MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-02. The listed applicant is Sage Laboratories, Inc.. The 510(k) number is K991112.

When did SAGE CONTRAST MANAGEMENT SYSTEM receive FDA 510(k) clearance?

SAGE CONTRAST MANAGEMENT SYSTEM received FDA 510(k) clearance on 1999-09-02, under 510(k) number K991112.

Who is the listed applicant for SAGE CONTRAST MANAGEMENT SYSTEM?

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

What is the FDA product code for SAGE CONTRAST MANAGEMENT SYSTEM?

The FDA product code for SAGE CONTRAST MANAGEMENT SYSTEM 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

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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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