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FDA 510(k)

MEDEGEN PRESSURE RATED EXTENSION SETS

K-Number: K083472 · 2008-12-09

ApplicantMedegen, Inc.
Decision Date2008-12-09
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDEGEN PRESSURE RATED EXTENSION SETS is the device name listed in this FDA 510(k) record. The listed applicant is Medegen, Inc.. It received FDA 510(k) clearance on 2008-12-09 under 510(k) number K083472. 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 MEDEGEN PRESSURE RATED EXTENSION SETS?

MEDEGEN PRESSURE RATED EXTENSION SETS is a medical device that received FDA 510(k) clearance on 2008-12-09. The listed applicant is Medegen, Inc.. The 510(k) number is K083472.

When did MEDEGEN PRESSURE RATED EXTENSION SETS receive FDA 510(k) clearance?

MEDEGEN PRESSURE RATED EXTENSION SETS received FDA 510(k) clearance on 2008-12-09, under 510(k) number K083472.

Who is the listed applicant for MEDEGEN PRESSURE RATED EXTENSION SETS?

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

What is the FDA product code for MEDEGEN PRESSURE RATED EXTENSION SETS?

The FDA product code for MEDEGEN PRESSURE RATED EXTENSION SETS 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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