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FDA 510(k)

PROTECTED NEEDLE WITH OR WITHOUT IV SET

K-Number: K903809 · 1990-10-03

ApplicantKendall Mcgaw Laboratories, Inc.
Decision Date1990-10-03
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROTECTED NEEDLE WITH OR WITHOUT IV SET 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 1990-10-03 under 510(k) number K903809. 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 PROTECTED NEEDLE WITH OR WITHOUT IV SET?

PROTECTED NEEDLE WITH OR WITHOUT IV SET is a medical device that received FDA 510(k) clearance on 1990-10-03. The listed applicant is Kendall Mcgaw Laboratories, Inc.. The 510(k) number is K903809.

When did PROTECTED NEEDLE WITH OR WITHOUT IV SET receive FDA 510(k) clearance?

PROTECTED NEEDLE WITH OR WITHOUT IV SET received FDA 510(k) clearance on 1990-10-03, under 510(k) number K903809.

Who is the listed applicant for PROTECTED NEEDLE WITH OR WITHOUT IV SET?

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 PROTECTED NEEDLE WITH OR WITHOUT IV SET?

The FDA product code for PROTECTED NEEDLE WITH OR WITHOUT IV SET 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.

K905611MICRORATE PLUS INTELLIGENT PUMPK905610MICRORATE INTELLIGENT PUMPK904855ADD-A-VIALK904518VOLUMETRIC INFUSION PUMPK901065INFUSION PUMPK900865ADD-A-VIAL II BINARY CONNECTOR

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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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