FDA 510(k)

Sweden & Martina Surgical Tray (Model ZSHORTY-INT)

Número K: K182084 · 2020-11-04

Data da decisão2020-11-04

Código do produtoKCT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is the device name listed in this FDA 510(k) record. The listed applicant is Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2020-11-04 under 510(k) number K182084. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sweden & Martina Surgical Tray (Model ZSHORTY-INT)?

Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is a medical device that received FDA 510(k) clearance on 2020-11-04. The listed applicant is Sweden & Martina S.P.A.. The 510(k) number is K182084.

When did Sweden & Martina Surgical Tray (Model ZSHORTY-INT) receive FDA 510(k) clearance?

Sweden & Martina Surgical Tray (Model ZSHORTY-INT) received FDA 510(k) clearance on 2020-11-04, under 510(k) number K182084.

Who is the listed applicant for Sweden & Martina Surgical Tray (Model ZSHORTY-INT)?

The FDA 510(k) record lists Sweden & Martina S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sweden & Martina Surgical Tray (Model ZSHORTY-INT)?

The FDA product code for Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is KCT.

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Outros registros que listam Sweden & Martina S.P.A. como candidato(a)

K222640Sweden & Martina Surgical Trays K180365PRAMA White Implant Systems K161989PREMIUM Implant Systems SHELTA Implant Systems K172560PREMIUM ONE Implant Systems K162028PREMIUM - SHELTA Prosthetic Components K162004PREMIUM Implant Systems SHELTA Implant Systems

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Dispositivos Relacionados (Código: KCT)

K253988LiteSet TraysNobel Biocare AB K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel Surgical K252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

Fonte oficial

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