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FDA 510(k)

STERIZONE VP4 Sterilizer

K-Number: K153392 · 2016-03-24

ApplicantTs03, Inc.
Decision Date2016-03-24
Product CodePJJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERIZONE VP4 Sterilizer is a medical device manufactured by Ts03, Inc.. It received FDA 510(k) clearance on 2016-03-24 under approval number K153392. The device is classified under product code PJJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERIZONE VP4 Sterilizer?

STERIZONE VP4 Sterilizer is a medical device that received FDA 510(k) clearance on 2016-03-24. It is manufactured by Ts03, Inc.. The 510(k) number is K153392.

When was STERIZONE VP4 Sterilizer approved by the FDA?

STERIZONE VP4 Sterilizer received FDA 510(k) clearance on 2016-03-24, under approval number K153392.

What company makes STERIZONE VP4 Sterilizer?

STERIZONE VP4 Sterilizer is manufactured by Ts03, Inc..

What is the FDA product code for STERIZONE VP4 Sterilizer?

The FDA product code for STERIZONE VP4 Sterilizer is PJJ.

Related Devices (Code: PJJ)

K153689STERIZONE SterilizerTso3, Inc. K172191STERIZONE VP4 SterilizerTso3, Inc. K173694STERIZONE VP4 SterilizerTso3, Inc. K190260STERIZONE(R) VP4 SterilizerTso3, 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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