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FDA 510(k)

SECONDARY IV SET WITH PROTECTED NEEDLE

K-Number: K895109 · 1989-09-27

ApplicantKendall Mcgaw Laboratories, Inc.
Decision Date1989-09-27
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SECONDARY IV SET WITH PROTECTED NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Mcgaw Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-27 under 510(k) number K895109. 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 SECONDARY IV SET WITH PROTECTED NEEDLE?

SECONDARY IV SET WITH PROTECTED NEEDLE is a medical device that received FDA 510(k) clearance on 1989-09-27. The listed applicant is Kendall Mcgaw Laboratories, Inc.. The 510(k) number is K895109.

When did SECONDARY IV SET WITH PROTECTED NEEDLE receive FDA 510(k) clearance?

SECONDARY IV SET WITH PROTECTED NEEDLE received FDA 510(k) clearance on 1989-09-27, under 510(k) number K895109.

Who is the listed applicant for SECONDARY IV SET WITH PROTECTED NEEDLE?

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

What is the FDA product code for SECONDARY IV SET WITH PROTECTED NEEDLE?

The FDA product code for SECONDARY IV SET WITH PROTECTED NEEDLE is FPA.

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Other records listing Kendall Mcgaw Laboratories, Inc. 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.

K905610MICRORATE INTELLIGENT PUMPK905611MICRORATE PLUS INTELLIGENT PUMPK904855ADD-A-VIALK904518VOLUMETRIC INFUSION PUMPK903809PROTECTED NEEDLE WITH OR WITHOUT IV SETK901065INFUSION PUMP

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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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