Life Essence Universal Porcelain System
FDA 510(k) K163251 · Blue Sky Bio
510(k) numberK163251
Submission
- Device name
- Life Essence Universal Porcelain System
- Applicant
- Blue Sky Bio
Grayslake, IL, US - Received
- November 18, 2016
- Decision date
- August 4, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Life Essence Universal Porcelain System cleared by the FDA?
Life Essence Universal Porcelain System (K163251) received a 510(k) decision of Substantially Equivalent on August 4, 2017, 259 days after the submission was received.
What is the product code of K163251?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.