FDA 510(k)

GenNarino

K-Number: K160799 · 2017-02-17

Decision Date2017-02-17

Product CodeLTF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GenNarino is the device name listed in this FDA 510(k) record. The listed applicant is Saliwell , Ltd.. It received FDA 510(k) clearance on 2017-02-17 under 510(k) number K160799. The device is classified under product code LTF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GenNarino?

GenNarino is a medical device that received FDA 510(k) clearance on 2017-02-17. The listed applicant is Saliwell , Ltd.. The 510(k) number is K160799.

When did GenNarino receive FDA 510(k) clearance?

GenNarino received FDA 510(k) clearance on 2017-02-17, under 510(k) number K160799.

Who is the listed applicant for GenNarino?

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

What is the FDA product code for GenNarino?

The FDA product code for GenNarino is LTF.

Other records listing Saliwell , Ltd. 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.

K232063SaliPen K220618SaliPen K180838SaliPen

Related Devices (Code: LTF)

K180838SaliPenSaliwell , Ltd.

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.