Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

K-Number: K160755 · 2016-07-27

ApplicantAhlstrom Nonwovens, LLC
Decision Date2016-07-27
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap is a medical device manufactured by Ahlstrom Nonwovens, LLC. It received FDA 510(k) clearance on 2016-07-27 under approval number K160755. 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 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap?

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2016-07-27. It is manufactured by Ahlstrom Nonwovens, LLC. The 510(k) number is K160755.

When was Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap approved by the FDA?

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap received FDA 510(k) clearance on 2016-07-27, under approval number K160755.

What company makes Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap?

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap is manufactured by Ahlstrom Nonwovens, LLC.

What is the FDA product code for Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap?

The FDA product code for Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap is FRG.

Other Devices by Ahlstrom Nonwovens, LLC

K171533Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

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. 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.

↑