FDA 510(k)

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse

Número K: K193336 · 2020-05-27

Data da decisão2020-05-27

Código do produtoOLR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse is the device name listed in this FDA 510(k) record. The listed applicant is Synedgen, Inc.. It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K193336. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse?

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Synedgen, Inc.. The 510(k) number is K193336.

When did Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse receive FDA 510(k) clearance?

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse received FDA 510(k) clearance on 2020-05-27, under 510(k) number K193336.

Who is the listed applicant for Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse?

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

What is the FDA product code for Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse?

The FDA product code for Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse is OLR.

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Outros registros que listam Synedgen, Inc. como candidato(a)

K172338Catasyn Advanced Technology Wound Hydrogel

Dispositivos Relacionados (Código: OLR)

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLC K251908Emanate TrayEmanate Biomedical K260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC

Fonte oficial

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