Thermoplastic Masks
K-Number: K192102 · 2019-09-25
ApplicantAktina Medical Corporation
Decision Date2019-09-25
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Thermoplastic Masks is a medical device manufactured by Aktina Medical Corporation. It received FDA 510(k) clearance on 2019-09-25 under approval number K192102. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Thermoplastic Masks?
Thermoplastic Masks is a medical device that received FDA 510(k) clearance on 2019-09-25. It is manufactured by Aktina Medical Corporation. The 510(k) number is K192102.
When was Thermoplastic Masks approved by the FDA?
Thermoplastic Masks received FDA 510(k) clearance on 2019-09-25, under approval number K192102.
What company makes Thermoplastic Masks?
Thermoplastic Masks is manufactured by Aktina Medical Corporation.
What is the FDA product code for Thermoplastic Masks?
The FDA product code for Thermoplastic Masks is IYE.
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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.