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FDA 510(k)

UNASSIGNED

K-Number: K080544 · 2008-08-14

ApplicantMedcomp
Decision Date2008-08-14
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNASSIGNED is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp. It received FDA 510(k) clearance on 2008-08-14 under 510(k) number K080544. 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 UNASSIGNED?

UNASSIGNED is a medical device that received FDA 510(k) clearance on 2008-08-14. The listed applicant is Medcomp. The 510(k) number is K080544.

When did UNASSIGNED receive FDA 510(k) clearance?

UNASSIGNED received FDA 510(k) clearance on 2008-08-14, under 510(k) number K080544.

Who is the listed applicant for UNASSIGNED?

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

What is the FDA product code for UNASSIGNED?

The FDA product code for UNASSIGNED is FPA.

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Other records listing Medcomp 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.

K123292T3K1029662.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICCK091954MICRO-STICK SETK092347PRO-PICC CTK091953PRO-PICCK090394VALVED TEARWAY INTRODUCER

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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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