rainbow LS Block
FDA 510(k) K160144 · Genoss Co., Ltd.
510(k) numberK160144
Submission
- Device name
- rainbow LS Block
- Applicant
- Genoss Co., Ltd.
Suwon-Si, KR - Received
- January 21, 2016
- Decision date
- July 21, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was rainbow LS Block cleared by the FDA?
rainbow LS Block (K160144) received a 510(k) decision of Substantially Equivalent on July 21, 2016, 182 days after the submission was received.
What is the product code of K160144?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.