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FDA 510(k)

MR EXTENSION SET (001)

K-Number: K964968 · 1997-02-27

ApplicantUniversity of Michigan
Decision Date1997-02-27
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MR EXTENSION SET (001) is the device name listed in this FDA 510(k) record. The listed applicant is University of Michigan. It received FDA 510(k) clearance on 1997-02-27 under 510(k) number K964968. 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 MR EXTENSION SET (001)?

MR EXTENSION SET (001) is a medical device that received FDA 510(k) clearance on 1997-02-27. The listed applicant is University of Michigan. The 510(k) number is K964968.

When did MR EXTENSION SET (001) receive FDA 510(k) clearance?

MR EXTENSION SET (001) received FDA 510(k) clearance on 1997-02-27, under 510(k) number K964968.

Who is the listed applicant for MR EXTENSION SET (001)?

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

What is the FDA product code for MR EXTENSION SET (001)?

The FDA product code for MR EXTENSION SET (001) is FPA.

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Other records listing University of Michigan 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.

K903403CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR

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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