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FDA 510(k)

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)

K-Number: K152669 · 2016-01-15

ApplicantPms Tip Teknolojileri Sanayi VE Ticaret Limited Std
Decision Date2016-01-15
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) is a medical device manufactured by Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std. It received FDA 510(k) clearance on 2016-01-15 under approval number K152669. 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 Self-Seal Sterilization Pouch with Chemical Indicator (KP)?

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) is a medical device that received FDA 510(k) clearance on 2016-01-15. It is manufactured by Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std. The 510(k) number is K152669.

When was PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) approved by the FDA?

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) received FDA 510(k) clearance on 2016-01-15, under approval number K152669.

What company makes PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)?

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) is manufactured by Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std.

What is the FDA product code for PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)?

The FDA product code for PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) 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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