BioSiCar Silicone Implant
K-Number: K193392 · 2020-07-20
ApplicantMetalware Technology Corp.
Decision Date2020-07-20
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
BioSiCar Silicone Implant is a medical device manufactured by Metalware Technology Corp.. It received FDA 510(k) clearance on 2020-07-20 under approval number K193392. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BioSiCar Silicone Implant?
BioSiCar Silicone Implant is a medical device that received FDA 510(k) clearance on 2020-07-20. It is manufactured by Metalware Technology Corp.. The 510(k) number is K193392.
When was BioSiCar Silicone Implant approved by the FDA?
BioSiCar Silicone Implant received FDA 510(k) clearance on 2020-07-20, under approval number K193392.
What company makes BioSiCar Silicone Implant?
BioSiCar Silicone Implant is manufactured by Metalware Technology Corp..
What is the FDA product code for BioSiCar Silicone Implant?
The FDA product code for BioSiCar Silicone Implant is MIB.
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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.