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FDA 510(k)

GENGIGEL MOUTHRINSE

K-Number: K053342 · 2007-03-13

ApplicantRicerfarma Srl
Decision Date2007-03-13
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

GENGIGEL MOUTHRINSE is the device name listed in this FDA 510(k) record. The listed applicant is Ricerfarma Srl. It received FDA 510(k) clearance on 2007-03-13 under 510(k) number K053342. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENGIGEL MOUTHRINSE?

GENGIGEL MOUTHRINSE is a medical device that received FDA 510(k) clearance on 2007-03-13. The listed applicant is Ricerfarma Srl. The 510(k) number is K053342.

When did GENGIGEL MOUTHRINSE receive FDA 510(k) clearance?

GENGIGEL MOUTHRINSE received FDA 510(k) clearance on 2007-03-13, under 510(k) number K053342.

Who is the listed applicant for GENGIGEL MOUTHRINSE?

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

What is the FDA product code for GENGIGEL MOUTHRINSE?

The FDA product code for GENGIGEL MOUTHRINSE is OLR.

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Related Devices (Code: OLR)

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.

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLCK251908Emanate TrayEmanate BiomedicalK260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC

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.

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