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FDA 510(k)

TSO3 OZONE STERILIZATION WRAP

K-Number: K080198 · 2008-05-30

ApplicantTso3, Inc.
Decision Date2008-05-30
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TSO3 OZONE STERILIZATION WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Tso3, Inc.. It received FDA 510(k) clearance on 2008-05-30 under 510(k) number K080198. 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 TSO3 OZONE STERILIZATION WRAP?

TSO3 OZONE STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 2008-05-30. The listed applicant is Tso3, Inc.. The 510(k) number is K080198.

When did TSO3 OZONE STERILIZATION WRAP receive FDA 510(k) clearance?

TSO3 OZONE STERILIZATION WRAP received FDA 510(k) clearance on 2008-05-30, under 510(k) number K080198.

Who is the listed applicant for TSO3 OZONE STERILIZATION WRAP?

The FDA 510(k) record lists Tso3, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSO3 OZONE STERILIZATION WRAP?

The FDA product code for TSO3 OZONE STERILIZATION WRAP is FRG.

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Other records listing Tso3, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190260STERIZONE(R) VP4 SterilizerK172191STERIZONE VP4 SterilizerK173694STERIZONE VP4 SterilizerK153689STERIZONE SterilizerK090636TSO3 OZONE STERILIZER, MODEL 125LK051595TSO3 OZONE STERILIZER, MODEL 125L

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Related Devices (Code: FRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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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