PRO-LITE Sterilization Tray
K-Number: K183402 · 2019-03-01
ApplicantSTERIS Corporation
Decision Date2019-03-01
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
PRO-LITE Sterilization Tray is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2019-03-01 under approval number K183402. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PRO-LITE Sterilization Tray?
PRO-LITE Sterilization Tray is a medical device that received FDA 510(k) clearance on 2019-03-01. It is manufactured by STERIS Corporation. The 510(k) number is K183402.
When was PRO-LITE Sterilization Tray approved by the FDA?
PRO-LITE Sterilization Tray received FDA 510(k) clearance on 2019-03-01, under approval number K183402.
What company makes PRO-LITE Sterilization Tray?
PRO-LITE Sterilization Tray is manufactured by STERIS Corporation.
What is the FDA product code for PRO-LITE Sterilization Tray?
The FDA product code for PRO-LITE Sterilization Tray is KCT.
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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.