FDA 510(k)

Dukal SMS Sterilization Wrap

K-Number: K233262 · 2024-03-22

Decision Date2024-03-22

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Dukal SMS Sterilization Wrap is a medical device manufactured by Dukal, LLC. It received FDA 510(k) clearance on 2024-03-22 under approval number K233262. 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 Dukal SMS Sterilization Wrap?

Dukal SMS Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Dukal, LLC. The 510(k) number is K233262.

When was Dukal SMS Sterilization Wrap approved by the FDA?

Dukal SMS Sterilization Wrap received FDA 510(k) clearance on 2024-03-22, under approval number K233262.

What company makes Dukal SMS Sterilization Wrap?

Dukal SMS Sterilization Wrap is manufactured by Dukal, LLC.

What is the FDA product code for Dukal SMS Sterilization Wrap?

The FDA product code for Dukal SMS Sterilization Wrap is FRG.

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Official Source

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