rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
FDA 510(k) K232174 · Genoss Co., Ltd.
510(k) numberK232174
Submission
- Device name
- rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
- Applicant
- Genoss Co., Ltd.
Hwaseong-Si, KR - Received
- July 21, 2023
- Decision date
- February 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono cleared by the FDA?
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono (K232174) received a 510(k) decision of Substantially Equivalent on February 23, 2024, 217 days after the submission was received.
What is the product code of K232174?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.