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FDA 510(k)

Tyvek Sterilization Pouches with Chevron Seal

K-Number: K170429 · 2017-10-27

ApplicantAndersen Sterilizers, Inc.
Decision Date2017-10-27
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Tyvek Sterilization Pouches with Chevron Seal is a medical device manufactured by Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2017-10-27 under approval number K170429. 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 Tyvek Sterilization Pouches with Chevron Seal?

Tyvek Sterilization Pouches with Chevron Seal is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Andersen Sterilizers, Inc.. The 510(k) number is K170429.

When was Tyvek Sterilization Pouches with Chevron Seal approved by the FDA?

Tyvek Sterilization Pouches with Chevron Seal received FDA 510(k) clearance on 2017-10-27, under approval number K170429.

What company makes Tyvek Sterilization Pouches with Chevron Seal?

Tyvek Sterilization Pouches with Chevron Seal is manufactured by Andersen Sterilizers, Inc..

What is the FDA product code for Tyvek Sterilization Pouches with Chevron Seal?

The FDA product code for Tyvek Sterilization Pouches with Chevron Seal is FRG.

Other Devices by Andersen Sterilizers, Inc.

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Related Devices (Code: FRG)

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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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