Rainbow Shine
FDA 510(k) K151842 · Genoss
510(k) numberK151842
Submission
- Device name
- Rainbow Shine
- Applicant
- Genoss
Suwon-Si, KR - Received
- July 7, 2015
- Decision date
- January 14, 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 Shine cleared by the FDA?
Rainbow Shine (K151842) received a 510(k) decision of Substantially Equivalent on January 14, 2016, 191 days after the submission was received.
What is the product code of K151842?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.