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FDA 510(k)

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

K-Number: K162362 · 2017-10-13

ApplicantPms Tibbi Cihazlar Teknolojisi San VE Tic AS
Decision Date2017-10-13
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Pms Tibbi Cihazlar Teknolojisi San VE Tic AS. The 510(k) number is K162362.

When was PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator approved by the FDA?

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

What company makes PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator?

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator is manufactured by Pms Tibbi Cihazlar Teknolojisi San VE Tic AS.

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.

Related Devices (Code: FRG)

K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation K152564Gemini Sterilization WrapMedline Industries, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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