Decision Date2018-10-23
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Cumulus Remover is a medical device manufactured by Kitazato Corporation. It received FDA 510(k) clearance on 2018-10-23 under approval number K182002. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cumulus Remover?
Cumulus Remover is a medical device that received FDA 510(k) clearance on 2018-10-23. It is manufactured by Kitazato Corporation. The 510(k) number is K182002.
When was Cumulus Remover approved by the FDA?
Cumulus Remover received FDA 510(k) clearance on 2018-10-23, under approval number K182002.
What company makes Cumulus Remover?
Cumulus Remover is manufactured by Kitazato Corporation.
What is the FDA product code for Cumulus Remover?
The FDA product code for Cumulus Remover is MQL.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.