FDA 510(k)

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

K-번호: K162362 · 2017-10-13

신청자Pms Tibbi Cihazlar Teknolojisi San VE Tic AS

결정일2017-10-13

제품 코드FRG

자문 위원회HO

결정Substantially Equivalent

기기 요약

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Pms Tibbi Cihazlar Teknolojisi San VE Tic AS. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K162362. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator?

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Pms Tibbi Cihazlar Teknolojisi San VE Tic AS. The 510(k) number is K162362.

When did PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator receive FDA 510(k) clearance?

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator received FDA 510(k) clearance on 2017-10-13, under 510(k) number K162362.

Who is the listed applicant for PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator?

The FDA 510(k) record lists Pms Tibbi Cihazlar Teknolojisi San VE Tic AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator?

The FDA product code for PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator is FRG.

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PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FRG)

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