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FDA 510(k)

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)

K-Number: K181959 · 2019-03-22

ApplicantOwens & Minor Halyard, Inc.
Decision Date2019-03-22
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is a medical device manufactured by Owens & Minor Halyard, Inc.. It received FDA 510(k) clearance on 2019-03-22 under approval number K181959. 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 HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)?

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by Owens & Minor Halyard, Inc.. The 510(k) number is K181959.

When was HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) approved by the FDA?

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) received FDA 510(k) clearance on 2019-03-22, under approval number K181959.

What company makes HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)?

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is manufactured by Owens & Minor Halyard, Inc..

What is the FDA product code for HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)?

The FDA product code for HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is FRG.

Other Devices by Owens & Minor Halyard, Inc.

K182096Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs

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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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