Life Essence Universal Porcelain System
K-Number: K163251 · 2017-08-04
ApplicantBlue Sky Bio
Decision Date2017-08-04
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Life Essence Universal Porcelain System is a medical device manufactured by Blue Sky Bio. It received FDA 510(k) clearance on 2017-08-04 under approval number K163251. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Life Essence Universal Porcelain System?
Life Essence Universal Porcelain System is a medical device that received FDA 510(k) clearance on 2017-08-04. It is manufactured by Blue Sky Bio. The 510(k) number is K163251.
When was Life Essence Universal Porcelain System approved by the FDA?
Life Essence Universal Porcelain System received FDA 510(k) clearance on 2017-08-04, under approval number K163251.
What company makes Life Essence Universal Porcelain System?
Life Essence Universal Porcelain System is manufactured by Blue Sky Bio.
What is the FDA product code for Life Essence Universal Porcelain System?
The FDA product code for Life Essence Universal Porcelain System is EIH.
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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.