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FDA 510(k)

SPLIT SEPTUM INJECTION SITES

K-Number: K041042 · 2004-07-16

ApplicantFresenius Medical Care North America
Decision Date2004-07-16
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPLIT SEPTUM INJECTION SITES is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care North America. It received FDA 510(k) clearance on 2004-07-16 under 510(k) number K041042. 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 SPLIT SEPTUM INJECTION SITES?

SPLIT SEPTUM INJECTION SITES is a medical device that received FDA 510(k) clearance on 2004-07-16. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K041042.

When did SPLIT SEPTUM INJECTION SITES receive FDA 510(k) clearance?

SPLIT SEPTUM INJECTION SITES received FDA 510(k) clearance on 2004-07-16, under 510(k) number K041042.

Who is the listed applicant for SPLIT SEPTUM INJECTION SITES?

The FDA 510(k) record lists Fresenius Medical Care North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPLIT SEPTUM INJECTION SITES?

The FDA product code for SPLIT SEPTUM INJECTION SITES is FPA.

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Other records listing Fresenius Medical Care North America as applicant

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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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