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FDA 510(k)

PROCESS CHANGE

K-Number: K810721 · 1981-04-23

ApplicantMedlon, Inc.
Decision Date1981-04-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROCESS CHANGE is the device name listed in this FDA 510(k) record. The listed applicant is Medlon, Inc.. It received FDA 510(k) clearance on 1981-04-23 under 510(k) number K810721. 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 PROCESS CHANGE?

PROCESS CHANGE is a medical device that received FDA 510(k) clearance on 1981-04-23. The listed applicant is Medlon, Inc.. The 510(k) number is K810721.

When did PROCESS CHANGE receive FDA 510(k) clearance?

PROCESS CHANGE received FDA 510(k) clearance on 1981-04-23, under 510(k) number K810721.

Who is the listed applicant for PROCESS CHANGE?

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

What is the FDA product code for PROCESS CHANGE?

The FDA product code for PROCESS CHANGE 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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