FDA 510(k)

GlassLok Kits, GlassLok Powder, GlassLok Liquid

Número K: K193388 · 2020-04-27

RequerenteReliance Orthodontic Products, Inc.

Data da decisão2020-04-27

Código do produtoDYH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

GlassLok Kits, GlassLok Powder, GlassLok Liquid is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K193388. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GlassLok Kits, GlassLok Powder, GlassLok Liquid?

GlassLok Kits, GlassLok Powder, GlassLok Liquid is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Reliance Orthodontic Products, Inc.. The 510(k) number is K193388.

When did GlassLok Kits, GlassLok Powder, GlassLok Liquid receive FDA 510(k) clearance?

GlassLok Kits, GlassLok Powder, GlassLok Liquid received FDA 510(k) clearance on 2020-04-27, under 510(k) number K193388.

Who is the listed applicant for GlassLok Kits, GlassLok Powder, GlassLok Liquid?

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

What is the FDA product code for GlassLok Kits, GlassLok Powder, GlassLok Liquid?

The FDA product code for GlassLok Kits, GlassLok Powder, GlassLok Liquid is DYH.

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Fonte oficial

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