Decision Date2018-05-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Irrigation Tubing Bipolar Cord Set is a medical device manufactured by New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2018-05-18 under approval number K180908. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Irrigation Tubing Bipolar Cord Set?
Irrigation Tubing Bipolar Cord Set is a medical device that received FDA 510(k) clearance on 2018-05-18. It is manufactured by New Deantronics Taiwan , Ltd.. The 510(k) number is K180908.
When was Irrigation Tubing Bipolar Cord Set approved by the FDA?
Irrigation Tubing Bipolar Cord Set received FDA 510(k) clearance on 2018-05-18, under approval number K180908.
What company makes Irrigation Tubing Bipolar Cord Set?
Irrigation Tubing Bipolar Cord Set is manufactured by New Deantronics Taiwan , Ltd..
What is the FDA product code for Irrigation Tubing Bipolar Cord Set?
The FDA product code for Irrigation Tubing Bipolar Cord Set is GEI.
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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.