ARTOURA Breast Tissue Expanders with Smooth Surface
K-Number: K161176 · 2016-05-23
ApplicantMentor Worldwide, LLC
Decision Date2016-05-23
Product CodeLCJ
DecisionSubstantially Equivalent
Device Summary
ARTOURA Breast Tissue Expanders with Smooth Surface is a medical device manufactured by Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2016-05-23 under approval number K161176. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ARTOURA Breast Tissue Expanders with Smooth Surface?
ARTOURA Breast Tissue Expanders with Smooth Surface is a medical device that received FDA 510(k) clearance on 2016-05-23. It is manufactured by Mentor Worldwide, LLC. The 510(k) number is K161176.
When was ARTOURA Breast Tissue Expanders with Smooth Surface approved by the FDA?
ARTOURA Breast Tissue Expanders with Smooth Surface received FDA 510(k) clearance on 2016-05-23, under approval number K161176.
What company makes ARTOURA Breast Tissue Expanders with Smooth Surface?
ARTOURA Breast Tissue Expanders with Smooth Surface is manufactured by Mentor Worldwide, LLC.
What is the FDA product code for ARTOURA Breast Tissue Expanders with Smooth Surface?
The FDA product code for ARTOURA Breast Tissue Expanders with Smooth Surface is LCJ.
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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.