Avance Gauze Dressing Kits
K-Number: K161948 · 2016-11-03
ApplicantMolnlycke Health Care Us, LLC
Decision Date2016-11-03
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Avance Gauze Dressing Kits is a medical device manufactured by Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2016-11-03 under approval number K161948. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Avance Gauze Dressing Kits?
Avance Gauze Dressing Kits is a medical device that received FDA 510(k) clearance on 2016-11-03. It is manufactured by Molnlycke Health Care Us, LLC. The 510(k) number is K161948.
When was Avance Gauze Dressing Kits approved by the FDA?
Avance Gauze Dressing Kits received FDA 510(k) clearance on 2016-11-03, under approval number K161948.
What company makes Avance Gauze Dressing Kits?
Avance Gauze Dressing Kits is manufactured by Molnlycke Health Care Us, LLC.
What is the FDA product code for Avance Gauze Dressing Kits?
The FDA product code for Avance Gauze Dressing Kits is OMP.
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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.