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FDA 510(k)

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

Número K: K160595 · 2016-11-18

RequerentePms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti
Data da decisão2016-11-18
Código do produtoFRG
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K160595. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator?

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti. The 510(k) number is K160595.

When did PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator receive FDA 510(k) clearance?

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator received FDA 510(k) clearance on 2016-11-18, under 510(k) number K160595.

Who is the listed applicant for PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator?

The FDA 510(k) record lists Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator?

The FDA product code for PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator is FRG.

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Dispositivos Relacionados (Código: FRG)

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