FDA 510(k)

INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,

K-Number: K092782 · 2009-12-07

Decision Date2009-12-07

Product CodeLHI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, is the device name listed in this FDA 510(k) record. The listed applicant is Carmel Pharma Ab.. It received FDA 510(k) clearance on 2009-12-07 under 510(k) number K092782. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,?

INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, is a medical device that received FDA 510(k) clearance on 2009-12-07. The listed applicant is Carmel Pharma Ab.. The 510(k) number is K092782.

When did INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, receive FDA 510(k) clearance?

INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, received FDA 510(k) clearance on 2009-12-07, under 510(k) number K092782.

Who is the listed applicant for INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,?

The FDA 510(k) record lists Carmel Pharma Ab. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,?

The FDA product code for INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, is LHI.

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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.