Sterile Dilator
K-Number: K192195 · 2019-09-26
ApplicantGalt Medical Corp.
Decision Date2019-09-26
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Sterile Dilator is a medical device manufactured by Galt Medical Corp.. It received FDA 510(k) clearance on 2019-09-26 under approval number K192195. 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 Sterile Dilator?
Sterile Dilator is a medical device that received FDA 510(k) clearance on 2019-09-26. It is manufactured by Galt Medical Corp.. The 510(k) number is K192195.
When was Sterile Dilator approved by the FDA?
Sterile Dilator received FDA 510(k) clearance on 2019-09-26, under approval number K192195.
What company makes Sterile Dilator?
Sterile Dilator is manufactured by Galt Medical Corp..
What is the FDA product code for Sterile Dilator?
The FDA product code for Sterile Dilator is DRE.
Other Devices by Galt Medical Corp.
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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.