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FDA 510(k)

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

K-Number: K160595 · 2016-11-18

ApplicantPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti
Decision Date2016-11-18
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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

When was PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator approved by the FDA?

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

What company makes PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator?

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator is manufactured by Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti.

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.

Related Devices (Code: FRG)

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. K152458Gemini Bonded 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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