U-Cem Premium & MAZIC Cem
K-Number: K193260 · 2020-08-21
ApplicantVericom Co., Ltd.
Decision Date2020-08-21
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
U-Cem Premium & MAZIC Cem is a medical device manufactured by Vericom Co., Ltd.. It received FDA 510(k) clearance on 2020-08-21 under approval number K193260. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the U-Cem Premium & MAZIC Cem?
U-Cem Premium & MAZIC Cem is a medical device that received FDA 510(k) clearance on 2020-08-21. It is manufactured by Vericom Co., Ltd.. The 510(k) number is K193260.
When was U-Cem Premium & MAZIC Cem approved by the FDA?
U-Cem Premium & MAZIC Cem received FDA 510(k) clearance on 2020-08-21, under approval number K193260.
What company makes U-Cem Premium & MAZIC Cem?
U-Cem Premium & MAZIC Cem is manufactured by Vericom Co., Ltd..
What is the FDA product code for U-Cem Premium & MAZIC Cem?
The FDA product code for U-Cem Premium & MAZIC Cem is EMA.
Other Devices by Vericom Co., Ltd.
Related Devices (Code: EMA)
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.