Avance Abdominal Dressing Kit
K-Number: K161939 · 2016-11-17
ApplicantMolnlycke Health Care Us, LLC
Decision Date2016-11-17
Product CodeOXJ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Avance Abdominal Dressing Kit is a medical device manufactured by Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2016-11-17 under approval number K161939. The device is classified under product code OXJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Avance Abdominal Dressing Kit?
Avance Abdominal Dressing Kit is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by Molnlycke Health Care Us, LLC. The 510(k) number is K161939.
When was Avance Abdominal Dressing Kit approved by the FDA?
Avance Abdominal Dressing Kit received FDA 510(k) clearance on 2016-11-17, under approval number K161939.
What company makes Avance Abdominal Dressing Kit?
Avance Abdominal Dressing Kit is manufactured by Molnlycke Health Care Us, LLC.
What is the FDA product code for Avance Abdominal Dressing Kit?
The FDA product code for Avance Abdominal Dressing Kit is OXJ.
Related Clinical Trials
Other Devices by Molnlycke Health Care Us, LLC
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.