FDA 510(k)

Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml

K-Number: K171805 · 2017-09-08

Decision Date2017-09-08

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml is the device name listed in this FDA 510(k) record. The listed applicant is Conceptomed AS. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K171805. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml?

Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Conceptomed AS. The 510(k) number is K171805.

When did Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml receive FDA 510(k) clearance?

Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml received FDA 510(k) clearance on 2017-09-08, under 510(k) number K171805.

Who is the listed applicant for Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml?

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

What is the FDA product code for Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml?

The FDA product code for Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml is FMF.

Other records listing Conceptomed AS 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.

K162057ConceptoMed Luer-Jack Slip 10ml

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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.