Benesta Medical Sterilization Tray
K-Number: K193603 · 2020-07-20
ApplicantCaldera Medical, Inc.
Decision Date2020-07-20
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Benesta Medical Sterilization Tray is a medical device manufactured by Caldera Medical, Inc.. It received FDA 510(k) clearance on 2020-07-20 under approval number K193603. 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 Benesta Medical Sterilization Tray?
Benesta Medical Sterilization Tray is a medical device that received FDA 510(k) clearance on 2020-07-20. It is manufactured by Caldera Medical, Inc.. The 510(k) number is K193603.
When was Benesta Medical Sterilization Tray approved by the FDA?
Benesta Medical Sterilization Tray received FDA 510(k) clearance on 2020-07-20, under approval number K193603.
What company makes Benesta Medical Sterilization Tray?
Benesta Medical Sterilization Tray is manufactured by Caldera Medical, Inc..
What is the FDA product code for Benesta Medical Sterilization Tray?
The FDA product code for Benesta Medical 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.