Infyna Chic
K-Number: K191633 · 2019-07-19
ApplicantHollister Incorporated
Decision Date2019-07-19
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Infyna Chic is a medical device manufactured by Hollister Incorporated. It received FDA 510(k) clearance on 2019-07-19 under approval number K191633. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Infyna Chic?
Infyna Chic is a medical device that received FDA 510(k) clearance on 2019-07-19. It is manufactured by Hollister Incorporated. The 510(k) number is K191633.
When was Infyna Chic approved by the FDA?
Infyna Chic received FDA 510(k) clearance on 2019-07-19, under approval number K191633.
What company makes Infyna Chic?
Infyna Chic is manufactured by Hollister Incorporated.
What is the FDA product code for Infyna Chic?
The FDA product code for Infyna Chic is GBM.
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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.