Dilator Sets
K-Number: K183036 · 2018-12-20
ApplicantCook Incorporated
Decision Date2018-12-20
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Dilator Sets is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-12-20 under approval number K183036. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dilator Sets?
Dilator Sets is a medical device that received FDA 510(k) clearance on 2018-12-20. It is manufactured by Cook Incorporated. The 510(k) number is K183036.
When was Dilator Sets approved by the FDA?
Dilator Sets received FDA 510(k) clearance on 2018-12-20, under approval number K183036.
What company makes Dilator Sets?
Dilator Sets is manufactured by Cook Incorporated.
What is the FDA product code for Dilator Sets?
The FDA product code for Dilator Sets is DRE.
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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.